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

NCT ID: NCT05414253

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Wound Heal; Surgical Wound; Impacted Third Molar Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Parallel Assignment

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Parallel Assignment

Intervention Type: DEVICE

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

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.

Group Type: PLACEBO_COMPARATOR

Parallel Assignment

Intervention Type: DEVICE

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

Interventions

Parallel Assignment

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Filippo Graziani, DDS MClinDent PhD

DDS MClinDent PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Pisa

Pisa, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Filippo Graziani

Role: CONTACT

filippograziani@med.unipi.it

+39050992772

Renato Porchia

Role: CONTACT

farmacovigilanza@aopisa.toscana.it

050/993179

Facility Contacts

Filippo Graziani

Role: primary

filippograziani@med.unipi.it

References

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.

Reference Type: RESULT

PMID: 20618550 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12795787 (View on PubMed)

Other Identifiers

CLOR_4

Identifier Type: -

Identifier Source: org_study_id