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

NCT06587880 | Recruiting Phase 4

• 2 other identifiers: 224000195284/2023-2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Extraction Socket Healing; Quality of Life; Postoperative Complications

Keywords

Clinical trial; Mouthwash; Socket healing; Postoperative complications; Quality of life

Outcome Measures

Primary Outcomes (1)

• Extraction socket soft tissue healing

  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.

Secondary Outcomes (16)

• Extraction socket Bone healing

  Radiographs will be taken at baseline and at 6 months after extraction.

• The resulting periodontal defect of the adjacent second molar

  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

  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

  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

  At 3, 7, 14 days, 3 and 6 months postoperatively.

Study Arms (4)

Bone Bioactive Liquid

ACTIVE COMPARATOR

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.

Drug: Bone Bioactive Liquid

Chlorhexidine Gluconate

ACTIVE COMPARATOR

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.

Drug: Chlorhexidine Gluconate

Warm Saline Mouth Rinse

ACTIVE COMPARATOR

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.

Drug: Warm Saline Mouth Rinse

Hyaluronic Acid mouthwash

ACTIVE COMPARATOR

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.

Drug: Hyaluronic Acid mouthwash

Interventions

Bone Bioactive Liquid DRUG

Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.

Bone Bioactive Liquid

Hyaluronic Acid mouthwash DRUG

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.

Hyaluronic Acid mouthwash

Warm Saline Mouth Rinse DRUG

Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.

Warm Saline Mouth Rinse

Chlorhexidine Gluconate DRUG

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.

Chlorhexidine Gluconate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

University of Jordan hospital

Amman, 11941, Jordan

RECRUITING

Related Publications (22)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 26991484 BACKGROUND

• 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.

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• 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.

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  PMID: 28529865 BACKGROUND

• 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.

  PMID: 14663809 BACKGROUND

• 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.

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• 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.

  PMID: 22976567 BACKGROUND

• 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.

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• 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.

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MeSH Terms

Conditions

Postoperative Complications

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmad Hamdan, Ph.D. in Periodontics

  Faculty of Dentistry - University of Jordan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad Hamdan, Ph.D. in Periodontics

CONTACT

+ 962779099199; Ahmad.hamdan@ju.edu.jo

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Periodontology

Model Details: The study coordinator will carry out the randomization as mentioned to have a list for the order in which interventions will be given, the same coordinator will prepare opaque bags, then they will move mouthwashes into new opaque bottles and put them in the bags at the same order in the randomization list, instructions sheets will be provided also for the specific mouthwash in the bag. The research assistant will have the bags without knowing what is inside them, they will give them to the surgeon after finishing the extraction procedure according to the assigned numbers of the patients which is determined according to the order of visits, the research assistant will leave the surgery room then the surgeon will open the bag to see the instructions to deliver them verbally to the patient and make sure they understand them fully then putting them back in the bag and giving it to the participant.

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 19, 2024
• Study Start: August 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning from publication with no end date
• Access Criteria: 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.

Locations

JO (1)