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The Effect of Different Types of Mouthwash on Extraction Sockets' Healing

3. května 2026 aktualizováno: 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:

  1. First group will receive BBL mouthwash.
  2. The second group will receive CHX mouthwash.
  3. The third group will be prescribed HA mouthwash.
  4. The fourth group will receive Warm Saline Mouth Rinse.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

100

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Ahmad Hamdan, Ph.D. in Periodontics
  • Telefonní číslo: + 962779099199
  • E-mail: Ahmad.hamdan@ju.edu.jo

Studijní místa

  • Jordán
      • Amman, Jordán, 11941
        • Nábor
        • University of Jordan hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Lék: Bone Bioactive Liquid
Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
Aktivní komparátor: 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.
Lék: Chlorhexidine Gluconate
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.
Aktivní komparátor: 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.
Lék: Warm Saline Mouth Rinse
Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
Aktivní komparátor: 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.
Lék: Hyaluronic Acid mouthwash
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Extraction socket soft tissue healing
Časové okno: Measured at 3, 7, 14 days, 3 and 6 months postoperatively.

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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Extraction socket Bone healing
Časové okno: Radiographs will be taken at baseline and at 6 months after extraction.
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).
Radiographs will be taken at baseline and at 6 months after extraction.
The resulting periodontal defect of the adjacent second molar
Časové okno: 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
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).
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
The resulting periodontal defect of the adjacent second molar
Časové okno: 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
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).
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
The resulting periodontal defect of the adjacent second molar
Časové okno: 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
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).
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
Quality of life of the patients (QOL) after extraction
Časové okno: At 3, 7, 14 days, 3 and 6 months postoperatively.
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.
At 3, 7, 14 days, 3 and 6 months postoperatively.
Pain at the extraction side
Časové okno: At 3, 7, 14 days, 3 and 6 months postoperatively.
Assessed using a 10cm long visual analog scale (VAS) where 0= no pain and 10= maximum amount of pain.
At 3, 7, 14 days, 3 and 6 months postoperatively.
Trismus
Časové okno: Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
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.
Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
Facial swelling at the extraction side
Časové okno: Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
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.
Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
Socio-demographic factors and medical history
Časové okno: Once preoperatively.
Data taken from participants using a form.
Once preoperatively.
Peri-operative factors
Časové okno: During the surgical procedure.
Operation time (min) categorized as <=20, >20 to 30, >30 to 40, >40.
During the surgical procedure.
Peri-operative factors
Časové okno: During the surgical procedure.
Amount of anesthesia administered.
During the surgical procedure.
Peri-operative factors
Časové okno: During the surgical procedure.
Tooth sectioning (done, not done).
During the surgical procedure.
Peri-operative factors
Časové okno: During the surgical procedure.
The surgeon's perception of difficulty categorized as <=9, >9 to 12, >12 to 16, >16.
During the surgical procedure.
Pre-operative factors
Časové okno: Once preoperatively.
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.
Once preoperatively.
Pre-operative factors
Časové okno: Once preoperatively.
Prior symptoms related to the third molar to be extracted categorized as: present, absent.
Once preoperatively.
Pre-operative factors
Časové okno: Once preoperatively.
Indication for the surgical extraction of the third molar categorized as: prophylactic extraction, pain related to the third molar, orthodontic indication.
Once preoperatively.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Jordan

Vyšetřovatelé

  • Vrchní vyšetřovatel: Ahmad Hamdan, Ph.D. in Periodontics, Faculty of Dentistry - University of Jordan

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. srpna 2025

Primární dokončení (Odhadovaný)

1. prosince 2026

Dokončení studie (Odhadovaný)

1. prosince 2026

Termíny zápisu do studia

První předloženo

31. srpna 2024

První předloženo, které splnilo kritéria kontroly kvality

4. září 2024

První zveřejněno (Aktuální)

19. září 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 224000195
  • 284/2023-2024 (Jiné číslo grantu/financování: University of Jordan)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

The plan is to share only IPD used in the results publication

Časový rámec sdílení IPD

Beginning from publication with no end date

Kritéria přístupu pro sdílení 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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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