Chlorhexidine Plus Hyaluronic Acid Mouthwash in Surgical Wound Healing Following Third Molar Surgery

NCT05414253 | Active Not Recruiting

• 1 other identifier: CLOR_4
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the response of gingival tissues to the use of mouthwash with chlorhexidine and chlorhexidine + hyaluronic acid in terms of healing of the surgical wound following third molar surgery.

Conditions

Wound Heal; Surgical Wound; Impacted Third Molar Tooth

Keywords

Chlorhexidine; Chlorhexidine gluconate; Anti-Infective Agents, Local; Wounds and Injuries; Mouth Diseases; Surgical Wound; Wound Heal

Outcome Measures

Primary Outcomes (1)

• Wound Healing Index (WHI) (Wachtel classification)

  Changes in WHI, measured orally through clinical examination on all the incisions, assigning a score from 1 to 5. Score 1: complete wound healing: absence of fibrin line in the interproximal area Score 2: complete wound healing: presence of a thin fibrin line in the interproximal area Score 3: complete wound healing: presence of fibrin clot in the interproximal area Score 4: incomplete wound healing: presence of partial necrosis of the interproximal area Score 5: incomplete wound healing: total necrosis of the interproximal area

  Measured at day 3, day 7, and day 14

Study Arms (3)

Test group 1

EXPERIMENTAL

Surgery will be performed following a standardized protocol by a single operator. The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision. Device: 0.2% chlorhexidine + anti-discoloration system + hyaluronic acid mouth rinse The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.

Device: Parallel Assignment

Test group 2

EXPERIMENTAL

Surgery will be performed following a standardized protocol by a single operator. The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision. Device: 0.2% chlorhexidine + anti-discoloration system mouth rinse The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.

Device: Parallel Assignment

Control Group

PLACEBO COMPARATOR

Surgery will be performed following a standardized protocol by a single operator. The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision. Device: placebo mouth rinse The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.

Device: Parallel Assignment

Interventions

Parallel Assignment DEVICE

Single-centre randomized, parallel design, clinical trial with a 2 week follow-up

Control Group; Test group 1; Test group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males or females of age range between 18 and 70 years,
• good health status,
• indication to perform third molar surgery,
• patients willing to give informed consent,
• compliance to the study follow-up,

You may not qualify if:

• pregnancy or breast-feeding,
• indication to antibiotic therapy prior to surgical treatment,
• chronic infections,
• systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
• previous therapy with the mouth rinses employed in the present study, and
• smoking habit (\>20 cigarettes per day, and/or pipe or cigar smoking).

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University Hospital of Pisa

Pisa, 56126, Italy

Location

Related Publications (2)

• Berchier CE, Slot DE, Van der Weijden GA. The efficacy of 0.12% chlorhexidine mouthrinse compared with 0.2% on plaque accumulation and periodontal parameters: a systematic review. J Clin Periodontol. 2010 Sep;37(9):829-39. doi: 10.1111/j.1600-051X.2010.01575.x. Epub 2010 Jul 7.

  PMID: 20618550 RESULT

• Wachtel H, Schenk G, Bohm S, Weng D, Zuhr O, Hurzeler MB. Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. J Clin Periodontol. 2003 Jun;30(6):496-504. doi: 10.1034/j.1600-051x.2003.00013.x.

  PMID: 12795787 RESULT

MeSH Terms

Conditions

Surgical Wound; Wounds and Injuries; Mouth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Principal Investigator

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: June 1, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)