The Effect of Different Types of Mouthwash on Extraction Sockets' Healing
3. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ahmad Hamdan, Ph.D. in Periodontics
- Telefonnummer: + 962779099199
- E-post: Ahmad.hamdan@ju.edu.jo
Studiesteder
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Amman, Jordan, 11941
- Rekruttering
- University of Jordan hospital
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Ta kontakt med:
- Ahmad Hamdan, Ph.D. in Periodontics
- Telefonnummer: + 962779099199
- E-post: Ahmad.hamdan@ju.edu.jo
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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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Aktiv komparator: 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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Aktiv komparator: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Extraction socket soft tissue healing
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Extraction socket Bone healing
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ahmad Hamdan, Ph.D. in Periodontics, Faculty of Dentistry - University of Jordan
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. august 2025
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
31. august 2024
Først innsendt som oppfylte QC-kriteriene
4. september 2024
Først lagt ut (Faktiske)
19. september 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 224000195
- 284/2023-2024 (Annet stipend/finansieringsnummer: University of Jordan)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The plan is to share only IPD used in the results publication
IPD-delingstidsramme
Beginning from publication with no end date
Tilgangskriterier for IPD-deling
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.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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