Evaluation of Chlorhexidine Plus Hyaluronic Acid Mouthwash in Surgical Wound Healing Following Third Molar Surgery (CLOR_4)

Wound Heal Clinical Trial

— CLOR_4  

Official title:

Evaluation of Chlorhexidine Plus Hyaluronic Acid Mouthwash in Surgical Wound Healing Following Third Molar Surgery (CLOR_4)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05414253
• Other study ID #: CLOR_4
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: June 2022
• Source: University of Pisa
• Contact: Filippo Graziani
• Phone: +39050992772
• Email: filippograziani[@]med.unipi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Wound healing following third molar surgery will be evaluated at the level of the flap incision. Surgical interventions will be performed following a standardized protocol by a single operator.

After surgery, patients will be randomly assigned to study groups corresponding to mouth rinse prescription. The mouth rinse will be assigned by an experimenter not involved in the following steps of the study, in order to maintain the examiner blind. The patient will receive a non-labelled mouth rinse to avoid biases both of the examiner and the patient. The patient will also be given a diary for the registration of the number of rinses per day, to be returned to the examiner at T14. The mouth rinse protocol assigned to each study participant includes a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.

The patients will be allocated in one of the three distinct study groups as it follows:

Group A: administration of 0.2% chlorhexidine + anti-discoloration system + hyaluronic acid mouth rinse (test group 1) Group B: administration of 0.2% chlorhexidine + anti-discoloration system mouth rinse (test group 2).

Group C: administration of placebo mouth rinse (control group)

Post-treatment photographs of surgical incision will be taken immediately after surgery and at 3 (T3), 7 (T7), and 14 (T14) days post-op, in order to allow the evaluation of the degree of wound healing. The degree of surgical healing will be evaluated using the Wound Healing Index - WHI (Wachtel classification) on all the incisions, and a score from 1 to 5 will be assigned.

At T3, T7, and T14 the following clinical parameters will be recorded for each patient:

oedema, trismus and pain level. The clinical examinations will be performed by calibrated examiner blind to group allocation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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,

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Surgical Wound
• Wound Heal
• Wounds and Injuries

Intervention

Device:
• Parallel Assignment
Single-centre randomized, parallel design, clinical trial with a 2 week follow-up

Locations

Country	Name	City	State
Italy	University Hospital of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

References & 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.2010.01 — View Citation

Wachtel H, Schenk G, Böhm S, Weng D, Zuhr O, Hürzeler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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