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

3 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Jordanië
      • Amman, Jordanië, 11941
        • Werving
        • University of Jordan hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Geneesmiddel: Bone Bioactive Liquid
Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
Actieve vergelijker: 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.
Geneesmiddel: 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.
Actieve vergelijker: 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.
Geneesmiddel: Warm Saline Mouth Rinse
Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
Actieve vergelijker: 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.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Extraction socket soft tissue healing
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Extraction socket Bone healing
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Once preoperatively.
Data taken from participants using a form.
Once preoperatively.
Peri-operative factors
Tijdsspanne: During the surgical procedure.
Operation time (min) categorized as <=20, >20 to 30, >30 to 40, >40.
During the surgical procedure.
Peri-operative factors
Tijdsspanne: During the surgical procedure.
Amount of anesthesia administered.
During the surgical procedure.
Peri-operative factors
Tijdsspanne: During the surgical procedure.
Tooth sectioning (done, not done).
During the surgical procedure.
Peri-operative factors
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Once preoperatively.
Prior symptoms related to the third molar to be extracted categorized as: present, absent.
Once preoperatively.
Pre-operative factors
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Jordan

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 augustus 2025

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

31 augustus 2024

Eerst ingediend dat voldeed aan de QC-criteria

4 september 2024

Eerst geplaatst (Werkelijk)

19 september 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

3 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 224000195
  • 284/2023-2024 (Ander subsidie-/financieringsnummer: University of Jordan)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

Beginning from publication with no end date

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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