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

Official title

A Randomized Controlled Trial on the Effect of Different Types of Mouthwash on the Healing of Extraction Sockets

Overview

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.

Interventions

• Drug 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.
• Drug Bone Bioactive Liquid
  Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
• Drug 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.
• Drug Warm Saline Mouth Rinse
  Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.

Primary outcome measures

• Extraction socket soft tissue healing [Time frame: Measured at 3, 7, 14 days, 3 and 6 months postoperatively.]

Secondary outcome measures (12)

• Extraction socket Bone healing [Time frame: Radiographs will be taken at baseline and at 6 months after extraction.]
• The resulting periodontal defect of the adjacent second molar [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: At 3, 7, 14 days, 3 and 6 months postoperatively.]
• Pain at the extraction side [Time frame: At 3, 7, 14 days, 3 and 6 months postoperatively.]
• Trismus [Time frame: Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.]
• Facial swelling at the extraction side [Time frame: Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.]
• Socio-demographic factors and medical history [Time frame: Once preoperatively.]
• Peri-operative factors [Time frame: During the surgical procedure.]
• Peri-operative factors [Time frame: During the surgical procedure.]
• Peri-operative factors [Time frame: During the surgical procedure.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Supportive care

Study locations

Jordan · 1 center

• University of Jordan hospital — Amman

Publications

• 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. PMID 24314857
• 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. PMID 34509363
• 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. PMID 28498604
• 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. PMID 32771444
• 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. PMID 32718882
• 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. PMID 30579747
• 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. PMID 29378998
• 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. PMID 24924267

Identifiers

NCT: NCT06587880 · 224000195 · 284/2023-2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗