NCT06920485

Brief Summary

INTRODUCTION: Local chemotherapeutic agents are used to reduce inflammation after impacted tooth extraction and to minimize possible complications, as well as to increase patient comfort. The aim of this study is to compare the clinical and microbiological effects of different mouthwashes/mouth rinses/antiseptic agents applied after impacted surgical tooth extraction in patients with impacted mandibular third molars within the scope of pain, wound healing and total bacterial load criteria; postoperative complications and healing process. MATERIAL AND METHODS: According to the Pell and Gregory classification, 96 volunteer patients with unilateral or bilateral Class 2 position A and B impacted mandibular third molars, being systemically healthy (ASA class 1), being between the ages of 18-45/young adult will participate in the study. The patients will be divided into 3 groups: Group 1, Patients who will be administered hypochlorous acid-containing mouthwash in addition to standard treatment after mandibular third molar surgery; Group 2, Patients who will be administered chlorhexidine gluconate-containing mouthwash in addition to standard treatment after mandibular third molar surgery; Group 3, Patients who will be administered sterile saline-containing mouthwash in addition to standard treatment after mandibular third molar surgery. Demographic data before the surgical procedure will be recorded in the patient follow-up form (Appendix-1). As a standard postoperative approach, all patients will be prescribed antibiotics (875 mg Amoxicillin+125 mg clavulonic acid, Augmentin-BID film-coated tablets, GlaxoSmithKline, Istanbul, Turkey), analgesics for use after surgery, and mouthwashes will be given depending on the groups. Patients will be asked to take antibiotics in the morning and evening for 5 days, use mouthwash for 7 days starting from the day after the procedure, and use mouthwash only when deemed necessary, and will be asked to record the amount they use on the home assessment form (ANNEX-2). All patients will be evaluated on the 7th day after the operation, and suture samples will be taken for microbiological load determination. All evaluations will be made before the operation and on the 7th day after the operation; and will be recorded on the patient assessment form (ANNEX-1). First of all, demographic information including age, gender, education level and the operation area will be recorded for all patients. Two separate forms with VAS scales for pain will be given to patients to mark every day for 7 days after the extraction. The patient will be asked to mark the level of pain they feel on the scale. The amount of analgesic use in the home assessment form will also be recorded within the scope of the pain assessment. Healing in the wound area will also be evaluated on the 7th day.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
May 2025Apr 2027

First Submitted

Initial submission to the registry

March 19, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

March 19, 2025

Last Update Submit

April 15, 2025

Conditions

Oral Health

Outcome Measures

Primary Outcomes (3)

  • Change in pain levels after mandibular third molar surgery

    Pain levels will be assessed daily for 7 days following mandibular third molar surgery using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Patients will complete the VAS form daily, and the average score across the 7-day period will be calculated for each participant. Unit of Measure: Visual Analog Scale score (0-10)

    From postoperative day 1 to day 7

  • Total bacterial load on suture materials evaluated by qPCR

    On postoperative day 7, suture materials will be collected from each participant. DNA will be isolated using a commercial extraction kit, and real-time polymerase chain reaction (qPCR) targeting the 16S ribosomal RNA (rRNA) gene will be performed to quantify total bacterial DNA. Results will be expressed as the number of 16S rRNA gene copies per sample. Unit of Measure: Copies of 16S rRNA gene per sample

    Postoperative day 7

  • Wound healing status on postoperative day 7

    The surgical site will be clinically evaluated for wound healing on day 7 after surgery using a standardized Early Wound Healing Index (EHI), which assesses clinical signs such as redness, swelling, bleeding, and epithelialization. The EHI is scored on a scale from 0 to 5, where 0 indicates very poor healing and 5 indicates excellent healing. Higher scores reflect better healing outcomes. Unit of Measure: Early Wound Healing Index score (0-5)

    Postoperative day 7

Secondary Outcomes (1)

  • Number of analgesic tablets consumed postoperatively

    From postoperative day 1 to day 7

Study Arms (3)

Hypochlorous acid

EXPERIMENTAL

Wound healing and microbiological analysis will be performed by administering hypochlorous acid to this group. All surgical procedures will be performed under local anesthesia (80 mg articaine hydrochloride and 0.02 mg epinephrine, Maxicaine Fort ampoule, Vem İlaç, İstanbul, Turkey) and sterile conditions following the application of inferior alveolar block anesthesia + buccal mucosa anesthesia. Osteotomy (bone removal) and, if necessary, root dissection will be performed using a surgical handpiece with sterile saline solution and irrigation. Following tooth extraction, the socket will be checked and any sharp bone protrusions will be removed. The area will be closed primarily using non-resorbable silk suture material (surgical silk suture, 3/0, Doğsan, Turkey).

Procedure: Third molar surgeryDiagnostic Test: Pain MedicineDiagnostic Test: Wound healingOther: Total bacterial load

Chlorhexidine gluconate

EXPERIMENTAL

Wound healing and microbiological analysis will be performed by administering chlorhexidine gluconate to this group. All surgical procedures will be performed under local anesthesia (80 mg articaine hydrochloride and 0.02 mg epinephrine, Maxicaine Fort ampoule, Vem İlaç, İstanbul, Turkey) and sterile conditions following the application of inferior alveolar block anesthesia + buccal mucosa anesthesia. Osteotomy (bone removal) and, if necessary, root dissection will be performed using a surgical handpiece with sterile saline solution and irrigation. Following tooth extraction, the socket will be checked and any sharp bone protrusions will be removed. The area will be closed primarily using non-resorbable silk suture material (surgical silk suture, 3/0, Doğsan, Turkey).

Procedure: Third molar surgeryDiagnostic Test: Pain MedicineDiagnostic Test: Wound healingOther: Total bacterial load

Physiological serum

EXPERIMENTAL

Wound healing and microbiological analysis will be performed by administering physiological serum to this group. All surgical procedures will be performed under local anesthesia (80 mg articaine hydrochloride and 0.02 mg epinephrine, Maxicaine Fort ampoule, Vem İlaç, İstanbul, Turkey) and sterile conditions following the application of inferior alveolar block anesthesia + buccal mucosa anesthesia. Osteotomy (bone removal) and, if necessary, root dissection will be performed using a surgical handpiece with sterile saline solution and irrigation. Following tooth extraction, the socket will be checked and any sharp bone protrusions will be removed. The area will be closed primarily using non-resorbable silk suture material (surgical silk suture, 3/0, Doğsan, Turkey).

Procedure: Third molar surgeryDiagnostic Test: Pain MedicineDiagnostic Test: Wound healingOther: Total bacterial load

Interventions

Third molar surgeryPROCEDURE

Effects of different gargles/mouth rinses/antiseptic agents applied after impacted surgical tooth extraction on postoperative wound healing and total bacterial load

Chlorhexidine gluconateHypochlorous acidPhysiological serum
Pain MedicineDIAGNOSTIC_TEST

After the extraction, patients will be given two separate forms with VAS scales for pain to mark every day for 7 days. The patient will be asked to mark the level of pain they feel on the scale. The amount of analgesic use on the home assessment form will also be recorded as part of the pain assessment. On the 7th day, healing in the wound area will also be assessed.

Chlorhexidine gluconateHypochlorous acidPhysiological serum
Wound healingDIAGNOSTIC_TEST

The degree of healing of the wound area will be checked using Landry scoring.

Chlorhexidine gluconateHypochlorous acidPhysiological serum
Total bacterial loadOTHER

Total bacterial load will be evaluated by microbiological analysis of sutures obtained from all groups.

Chlorhexidine gluconateHypochlorous acidPhysiological serum

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a mandibular third molar with a unilateral or bilateral Class 2, Position A or B impaction according to the Pell and Gregory classification
  • Being systemically healthy (ASA Class I)
  • Aged between 18 and 45 years (young adult age group)
  • Willingness to participate in the study

You may not qualify if:

  • Age outside the specified range
  • Pregnancy
  • Currently breastfeeding
  • Presence of infection in the third molar region (e.g., acute pericoronitis)
  • Presence of cystic or tumoral lesions associated with the impacted third molar
  • History of allergic reactions
  • Presence of any systemic disease
  • Unwillingness to participate in the study
  • Poor oral hygiene that may negatively affect healing
  • Smoking or alcohol addiction
  • Use of antibiotics or mouthwash in the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Wound Healing

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 19, 2025

First Posted

April 9, 2025

Study Start

May 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Patient information will be kept confidential.

Locations

TU(1)