Evaluation of Hyaluronic Acid and Chlorhexidine Gel as an Adjunct to Minimally Invasive Non-surgical Therapy in the Treatment of Stage III and IV... | NCT07731113

NCT07731113

Overview

NCT ID: NCT07731113
Lead Sponsor: Cairo UniversityOTHER
Official Title: Evaluation of Hyaluronic Acid and Chlorhexidine Gel as an Adjunct to Minimally Invasive Non-surgical Therapy in the Treatment of Stage III and IV Periodontitis: A Randomized Clinical Trial
Brief Summary: Stage III and IV periodontitis are advanced forms of periodontal disease characterized by significant attachment loss, deep periodontal pockets, and progressive destruction of supporting periodontal tissues. Minimally invasive non-surgical therapy (MINST) has been proposed as an effective treatment approach aimed at minimizing tissue trauma while achieving optimal biofilm and calculus removal. Adjunctive therapies may further enhance clinical outcomes by promoting wound healing and reducing inflammation.

This randomized clinical trial aims to evaluate the effectiveness of a hyaluronic acid and chlorhexidine gel (Periofix Plus Gel) used as an adjunct to MINST in patients with Stage III and IV periodontitis. Participants will be randomly assigned to receive either MINST alone or MINST combined with local application of the hyaluronic acid/chlorhexidine gel. Clinical periodontal parameters, including probing pocket depth, clinical attachment level, bleeding on probing, and plaque-related indices, will be assessed at baseline and follow-up visits to determine whether adjunctive gel application provides additional clinical benefits compared with MINST alone.

The study hypothesis is that the adjunctive use of hyaluronic acid and chlorhexidine gel following MINST will result in greater periodontal pocket reduction, improved clinical attachment gain, and enhanced soft tissue healing compared with MINST alone.

Status and Timeline

Status: Active, not recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Mar 1, 2026Actual
Primary Completion Date: Dec 10, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

1. Age 25-70 2. Diagnosis of 'periodontitis' stage III or IV (grades A to C) 3. Presence of ≥ 1 'intrabony defect' (PPD, > 5 mm with intrabony defect depth ≥ 3 mm at screening radiograph) 4. Signed informed consent

Exclusion Criteria:

1. Smoking (current or in past 5 years) 2. Medical history including diabetes or hepatic or renal disease or other serious medical conditions or transmittable diseases 3. History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures 4. Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam 5. Systemic antibiotic therapy during the 3 months preceding the baseline exam 6. History of alcohol or drug abuse 7. Self-reported pregnancy or lactation 8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation 9. Periodontal treatment to the study site within the last 12 months

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 72Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: Faculty of Oral and Dental Medicine. Cairo University

Similar Studies

Participant Group/Arms

ControlActive Comparator

The control group will receive MINST only for the treatment of deep periodontal pockets. The application of MINST minimizes soft and hard tissue trauma achieving better treatment outcomes in comparison with traditional scaling and root planing. Gingival architecture is maintained, and stability of the area is preserved favoring better clot formation and stabilization

Procedure: MINST

TestExperimental

Test intervention (MINST + CHX+HA gel): Participants will receive Minimally Invasive Non-Surgical Therapy (MINST) for the treatment of deep periodontal pockets. Immediately after instrumentation, a chlorhexidine (CHX) and hyaluronic acid (HA) gel will be applied subgingivally into the treated periodontal pockets as an adjunct to MINST. The gel is intended to provide local antimicrobial activity while supporting soft tissue healing and periodontal wound repair. Gel used: Periofix Plus GEL (Intermed S.A. Pharmaceutical Laboratories, Greece)

Procedure: MINST + CHX+HA gel