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

Sponsor

University of Pisa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05414253

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Heal Surgical Wound Impacted Third Molar Tooth	Device: Parallel Assignment	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test group 1 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 Single-centre randomized, parallel design, clinical trial with a 2 week follow-up
Experimental: Test group 2 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 Single-centre randomized, parallel design, clinical trial with a 2 week follow-up
Placebo Comparator: Control Group 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 Single-centre randomized, parallel design, clinical trial with a 2 week follow-up

Arm

Intervention/Treatment

Experimental: Test group 1

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

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

Experimental: Test group 2

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

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

Placebo Comparator: Control Group

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

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

Outcome Measures

Primary Outcome Measures

Wound Healing Index (WHI) (Wachtel classification) [Measured at day 3, day 7, and day 14]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).