The Effect of Different Types of Mouthwash on Extraction Sockets' Healing
3 maggio 2026 aggiornato da: Ahmad Abdel-Salam Hamdan, University of Jordan
A Randomized Controlled Trial on the Effect of Different Types of Mouthwash on the Healing of Extraction Sockets
The goal of this clinical trial is to assess the effect of four different types of mouthwash on socket healing after surgical extractions in male or female patients aged 18 years and older who have a unilateral impacted mandibular third molar indicated for extraction. The main questions it aims to answer are:
The effect of Bone Bioactive Liquid (BBL) mouthwash, Hyaluronic Acid (HA) mouthwash, the Chlorhexidine digluconate (CHX) mouthwash and Warm Saline Mouth Rinse (WSMR) on socket healing after surgical extractions.
The effect of BBL mouthwash, HA mouthwash, the CHX mouthwash and WSMR on patient related factors and their quality of life.
Recruited Participants will be randomized into four intervention groups:
- First group will receive BBL mouthwash.
- The second group will receive CHX mouthwash.
- The third group will be prescribed HA mouthwash.
- The fourth group will receive Warm Saline Mouth Rinse.
Panoramica dello studio
Stato
Stato
Reclutamento
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
Iscrizione
100
Fase
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Ahmad Hamdan, Ph.D. in Periodontics
- Numero di telefono: + 962779099199
- Email: Ahmad.hamdan@ju.edu.jo
Luoghi di studio
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Amman, Giordania, 11941
- Reclutamento
- University of Jordan hospital
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Contatto:
- Ahmad Hamdan, Ph.D. in Periodontics
- Numero di telefono: + 962779099199
- Email: Ahmad.hamdan@ju.edu.jo
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Male or female patients aged 18 years and older who have a unilateral impacted mandibular third molar that is indicated for extraction with bone removal and the presence of an adjacent second molar.
Exclusion Criteria:
- Soft tissue impaction that will not need any bone removal.
- Presence of any acute oral infection including active Pericoronitis.
- Patients who have undergone radiotherapy in the head and neck region, chemotherapy or systemic long-term corticosteroid treatment.
- Patients receiving medications known to induce gingival hyperplasia; anticonvulsant (phenytoin), immunosuppressant (cyclosporine A), and various calcium channel blockers (nifedipine, verapamil, diltiazem).
- Patients who have taken systemic antibiotics less than 3 months prior to baseline.
- Presence of uncontrolled diabetes, severe nutritional deficiencies and endocrine disturbances.
- Presence of immune deficiency or any immune disease.
- Intravenous bisphosphonates or Oral bisphosphonate intake for more than 3 years.
- Smokers and alcoholics.
- Pregnant or lactating females.
- Hypersensitivity to one of the ingredients listed in any of the mouthwashes, especially chlorhexidine as reactions to this has been reported in the literature.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
4
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Comparatore attivo: Bone Bioactive Liquid
Bone bioactive liquid (BBL) is a saline solution used as a mouthwash that contains calcium chloride (CaCl2) and magnesium dichloride hexahydrate (MgCl2-6H2O) with a net negative charge.
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Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
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Comparatore attivo: Chlorhexidine Gluconate
It is a strong bisbiguanide base, with cationic structure at physiological pH (positively charged), and has a broad-spectrum antibacterial activity that works against Gram-positive and Gram- negative bacteria and certain mycetes.
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Prescribed for 7 days period 2 times a day starting 24 hours post-extraction, the patient is instructed to pour 10 ml of the mouthwash into a measuring cup, rinse for 1 minute at an alternative time to teeth brushing.
Do not eat or drink for 30 min after use.
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Comparatore attivo: Warm Saline Mouth Rinse
Prescribing WSMR as a prophylactic postoperatively is due to the fact that the heat of the solution results in a therapeutic increase in blood flow to the extraction socket.
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Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
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Comparatore attivo: Hyaluronic Acid mouthwash
It is a high molecular weight non-sulphated polysaccharide.
It is biocompatible, non-immunogenic, biodegradable, viscoelastic that make it a preferable biomaterial for medical and pharmaceutical applications without adverse events.
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Prescribed for 7 days period 3-4 times a day starting 24 hours post-extraction, the patient is instructed to pour 20 ml of the mouthwash into a measuring cup and rinse for 1 minute, at an alternative time to teeth brushing.
Do not eat or drink for 30 mins after use.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Extraction socket soft tissue healing
Lasso di tempo: Measured at 3, 7, 14 days, 3 and 6 months postoperatively.
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Using a new socket wound healing scale that is a combination of the gingival healing index of Landry et al. and the wound healing scale used by Cervelli et al. to assess the post-extraction wounds in terms of wound dehiscence, epithelialization, quality of granulation tissue filling the post-extraction socket, and depth between early granulation tissue and wound margin. A blunt periodontal probe with millimetric markers will be used for this assessment to score a number between 0 (best) and 4 (worst) for the healing socket. |
Measured at 3, 7, 14 days, 3 and 6 months postoperatively.
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Extraction socket Bone healing
Lasso di tempo: Radiographs will be taken at baseline and at 6 months after extraction.
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Using panoramic radiographs and following the Longitudinal radiographic assessment (LRA) technique categorized as: A. The empty socket is completely radiolucent, and lamina dura is observed clearly around the socket.
B. Socket region is hazy and lamina dura is observed around the socket.
C.
There is a mixed radiolucent-radiopaque appearance inside the socket and lamina dura has been partially disappeared.
D. Mature bone is seen inside the socket and lamina dura has disappeared completely (no difference between the socket and normal bone).
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Radiographs will be taken at baseline and at 6 months after extraction.
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The resulting periodontal defect of the adjacent second molar
Lasso di tempo: Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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Will be evaluated using a UNC 15 perio probe with three clinical parameters: the first is probing depth (PD) measured in mm at three sites of the second molar tooth: Distal (D), disto-buccal (DB), and disto-lingual (DL).
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Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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The resulting periodontal defect of the adjacent second molar
Lasso di tempo: Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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Will be evaluated using a UNC 15 perio probe with three clinical parameters: the second is gingival recession (GR) measured in mm at three sites of the second molar tooth: Distal (D), disto-buccal (DB), and disto-lingual (DL).
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Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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The resulting periodontal defect of the adjacent second molar
Lasso di tempo: Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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Will be evaluated using a UNC 15 perio probe with three clinical parameters: the third is bleeding on probing (BOP) measured as present or not at three sites of the second molar tooth: Distal (D), disto-buccal (DB), and disto-lingual (DL).
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Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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Quality of life of the patients (QOL) after extraction
Lasso di tempo: At 3, 7, 14 days, 3 and 6 months postoperatively.
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Assessed based on a questionnaire that addresses different aspects including social and work isolation, ability to eat and speak, impairment of sleep schedule, their physical appearance related to swelling, bleeding and Paresthesia.
Answers to the presented questions are in the form of a four-point scale regarding their experience at the time the participants given the form to fill.
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At 3, 7, 14 days, 3 and 6 months postoperatively.
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Pain at the extraction side
Lasso di tempo: At 3, 7, 14 days, 3 and 6 months postoperatively.
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Assessed using a 10cm long visual analog scale (VAS) where 0= no pain and 10= maximum amount of pain.
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At 3, 7, 14 days, 3 and 6 months postoperatively.
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Trismus
Lasso di tempo: Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
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By measuring the interincisal distance at the maximum mouth opening pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively, then the difference between pre- and postoperative will be taken.
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Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
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Facial swelling at the extraction side
Lasso di tempo: Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
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Assessed using a soft tape to measure the distance between the lowest point of the tragus and the soft tissue pogonion, the lowest point of the tragus and the lateral corner of the mouth, the lateral corner of the eye and the angle of the mandible.
These measurements will be taken preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
Then the difference between the pre-operative and postoperative values will be divided by the value obtained in the preoperative period and multiplied by 100 to have the final percentage for the post-operative day.
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Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
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Socio-demographic factors and medical history
Lasso di tempo: Once preoperatively.
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Data taken from participants using a form.
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Once preoperatively.
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Peri-operative factors
Lasso di tempo: During the surgical procedure.
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Operation time (min) categorized as <=20, >20 to 30, >30 to 40, >40.
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During the surgical procedure.
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Peri-operative factors
Lasso di tempo: During the surgical procedure.
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Amount of anesthesia administered.
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During the surgical procedure.
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Peri-operative factors
Lasso di tempo: During the surgical procedure.
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Tooth sectioning (done, not done).
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During the surgical procedure.
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Peri-operative factors
Lasso di tempo: During the surgical procedure.
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The surgeon's perception of difficulty categorized as <=9, >9 to 12, >12 to 16, >16.
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During the surgical procedure.
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Pre-operative factors
Lasso di tempo: Once preoperatively.
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The radiographic anatomical relationship between the tooth roots and mandibular canal as it appears on the radiographic image taken preoperatively, categorized as: No association between root structure and the superior border of the canal, Root structure impinging the superior border of canal, Overlapping root structure and canal.
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Once preoperatively.
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Pre-operative factors
Lasso di tempo: Once preoperatively.
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Prior symptoms related to the third molar to be extracted categorized as: present, absent.
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Once preoperatively.
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Pre-operative factors
Lasso di tempo: Once preoperatively.
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Indication for the surgical extraction of the third molar categorized as: prophylactic extraction, pain related to the third molar, orthodontic indication.
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Once preoperatively.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Ahmad Hamdan, Ph.D. in Periodontics, Faculty of Dentistry - University of Jordan
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Araujo MG, Silva CO, Misawa M, Sukekava F. Alveolar socket healing: what can we learn? Periodontol 2000. 2015 Jun;68(1):122-34. doi: 10.1111/prd.12082.
- Afat IM, Akdogan ET, Gonul O. Effects of leukocyte- and platelet-rich fibrin alone and combined with hyaluronic acid on early soft tissue healing after surgical extraction of impacted mandibular third molars: A prospective clinical study. J Craniomaxillofac Surg. 2019 Feb;47(2):280-286. doi: 10.1016/j.jcms.2018.11.023. Epub 2018 Dec 3.
- Varoni E, Tarce M, Lodi G, Carrassi A. Chlorhexidine (CHX) in dentistry: state of the art. Minerva Stomatol. 2012 Sep;61(9):399-419. English, Italian.
- Ibraheem W, Jedaiba WH, Alnami AM, Hussain Baiti LA, Ali Manqari SM, Bhati A, Almarghlani A, Assaggaf M. Efficacy of hyaluronic acid gel and spray in healing of extraction wound: a randomized controlled study. Eur Rev Med Pharmacol Sci. 2022 May;26(10):3444-3449. doi: 10.26355/eurrev_202205_28838.
- Kim JJ, Song HY, Ben Amara H, Kyung-Rim K, Koo KT. Hyaluronic Acid Improves Bone Formation in Extraction Sockets With Chronic Pathology: A Pilot Study in Dogs. J Periodontol. 2016 Jul;87(7):790-5. doi: 10.1902/jop.2016.150707. Epub 2016 Mar 18.
- Koray M, Ofluoglu D, Onal EA, Ozgul M, Ersev H, Yaltirik M, Tanyeri H. Efficacy of hyaluronic acid spray on swelling, pain, and trismus after surgical extraction of impacted mandibular third molars. Int J Oral Maxillofac Surg. 2014 Nov;43(11):1399-403. doi: 10.1016/j.ijom.2014.05.003. Epub 2014 Jun 10.
- Sasaki T, Watanabe C. Stimulation of osteoinduction in bone wound healing by high-molecular hyaluronic acid. Bone. 1995 Jan;16(1):9-15. doi: 10.1016/s8756-3282(94)00001-8.
- Yamada SI, Hasegawa T, Yoshimura N, Hakoyama Y, Nitta T, Hirahara N, Miyamoto H, Yoshimura H, Ueda N, Yamamura Y, Okuyama H, Takizawa A, Nakanishi Y, Iwata E, Akita D, Itoh R, Kubo K, Kondo S, Hata H, Koyama Y, Miyamoto Y, Nakahara H, Akashi M, Kirita T, Shibuya Y, Umeda M, Kurita H. Prevalence of and risk factors for postoperative complications after lower third molar extraction: A multicenter prospective observational study in Japan. Medicine (Baltimore). 2022 Aug 12;101(32):e29989. doi: 10.1097/MD.0000000000029989.
- Osunde OD, Adebola RA, Adeoye JB, Bassey GO. Comparative study of the effect of warm saline mouth rinse on complications after dental extractions. Int J Oral Maxillofac Surg. 2014 May;43(5):649-53. doi: 10.1016/j.ijom.2013.09.016. Epub 2013 Dec 5.
- Adekunle AA, Egbunah UP, Erinoso OA, Adeyemo WL. Effectiveness of warm saline mouth bath in preventing alveolar osteitis: A systematic review and meta-analysis. J Craniomaxillofac Surg. 2021 Oct;49(10):980-988. doi: 10.1016/j.jcms.2021.09.001. Epub 2021 Sep 4.
- Cho H, Lynham AJ, Hsu E. Postoperative interventions to reduce inflammatory complications after third molar surgery: review of the current evidence. Aust Dent J. 2017 Dec;62(4):412-419. doi: 10.1111/adj.12526. Epub 2017 Jun 14.
- Maria de Souza G, Elias GM, Pereira de Andrade PF, Andrade Sales KN, Galvao EL, Moreira Falci SG. The Effectiveness of Hyaluronic Acid in Controlling Pain, Edema, and Trismus After Extraction of Third Molars: Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2020 Dec;78(12):2154.e1-2154.e12. doi: 10.1016/j.joms.2020.07.005. Epub 2020 Jul 14.
- Canellas JVDS, Fraga SRG, Santoro MF, Netto JNS, Tinoco EMB. Intrasocket interventions to prevent alveolar osteitis after mandibular third molar surgery: A systematic review and network meta-analysis. J Craniomaxillofac Surg. 2020 Sep;48(9):902-913. doi: 10.1016/j.jcms.2020.06.012. Epub 2020 Jul 8.
- Yilmaz N, Demirtas N, Kazancioglu HO, Bayer S, Acar AH, Mihmanli A. The efficacy of hyaluronic acid in postextraction sockets of impacted third molars: A pilot study. Niger J Clin Pract. 2017 Dec;20(12):1626-1631. doi: 10.4103/1119-3077.224131.
- Gocmen G, Gonul O, Oktay NS, Yarat A, Goker K. The antioxidant and anti-inflammatory efficiency of hyaluronic acid after third molar extraction. J Craniomaxillofac Surg. 2015 Sep;43(7):1033-7. doi: 10.1016/j.jcms.2015.04.022. Epub 2015 May 6.
- Rodrigues SV, Acharya AB, Bhadbhade S, Thakur SL. Hyaluronan-containing mouthwash as an adjunctive plaque-control agent. Oral Health Prev Dent. 2010;8(4):389-94.
- Romano CL, De Vecchi E, Bortolin M, Morelli I, Drago L. Hyaluronic Acid and Its Composites as a Local Antimicrobial/Antiadhesive Barrier. J Bone Jt Infect. 2017 Jan 1;2(1):63-72. doi: 10.7150/jbji.17705. eCollection 2017.
- Phillips C, White RP Jr, Shugars DA, Zhou X. Risk factors associated with prolonged recovery and delayed healing after third molar surgery. J Oral Maxillofac Surg. 2003 Dec;61(12):1436-48. doi: 10.1016/j.joms.2003.08.003.
- Gizligoz B, Ince Kuka G, Tunar OL, Ozkan Karaca E, Gursoy H, Kuru B. Plaque Inhibitory Effect of Hyaluronan-Containing Mouthwash in a 4-Day Non-Brushing Model. Oral Health Prev Dent. 2020 Feb 14;18(1):61-70. doi: 10.3290/j.ohpd.a43936.
- Ferres-Amat E, Al Madhoun A, Ferres-Amat E, Al Demour S, Ababneh MA, Ferres-Padro E, Marti C, Carrio N, Barajas M, Atari M. Histologic and Histomorphometric Evaluation of a New Bioactive Liquid BBL on Implant Surface: A Preclinical Study in Foxhound Dogs. Materials (Basel). 2021 Oct 19;14(20):6217. doi: 10.3390/ma14206217.
- Ferres-Amat E, Al Madhoun A, Ferres-Amat E, Carrio N, Barajas M, Al-Madhoun AS, Ferres-Padro E, Marti C, Atari M. Comparison of 0.12% Chlorhexidine and a New Bone Bioactive Liquid, BBL, in Mouthwash for Oral Wound Healing: A Randomized, Double Blind Clinical Human Trial. J Pers Med. 2022 Oct 16;12(10):1725. doi: 10.3390/jpm12101725.
- Oginni FO, Ugboko VI, Assam E, Ogunbodede EO. Postoperative complaints following impacted mandibular third molar surgery in Ile-Ife, Nigeria. SADJ. 2002 Jul;57(7):264-8.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
10 agosto 2025
Completamento primario (Stimato)
Completamento primario
1 dicembre 2026
Completamento dello studio (Stimato)
Completamento dello studio
1 dicembre 2026
Date di iscrizione allo studio
Primo inviato
Primo inviato
31 agosto 2024
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
4 settembre 2024
Primo Inserito (Effettivo)
Primo Inserito
19 settembre 2024
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
7 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 maggio 2026
Ultimo verificato
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 224000195
- 284/2023-2024 (Altro numero di sovvenzione/finanziamento: University of Jordan)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
The plan is to share only IPD used in the results publication
Periodo di condivisione IPD
Beginning from publication with no end date
Criteri di accesso alla condivisione IPD
The principal investigator will review requests for IPD sharing according to the predetermined set of criteria.
The criteria that must be met in order for data to be shared are: having a study protocol that has been approved by an independent review committee identified for IPD meta-analyses.
The study protocol must be submitted through email then when reviewed data requestors will need to sign a data access agreement.
The data requestor will be provided with the IPD file that can be accessed by them only by having their email listed as a viewer in the sharing list of a folder stored on the DropBox website, this folder has the data excel sheet file and the study protocol as the supporting material.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .