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
NCT07731113 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2026-08-07
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.
Conditions
- Periodontology
- Periodontal Disease
- Periodontal Diseases
- Periodontitis (Stage 3)
- Gingivitis and Periodontal Diseases
- Stage III Periodontitis
- Stage IV Periodontitis
- Minimally Invasive Non-Surgical Therapy (MINST)
- Non-Surgical Periodontal Therapy
- Hyaluronic Acid
- Hyaluronic Acid and Chlorhexidine Gel
- Periofix Plus Gel
- Adjunctive Periodontal Therapy
- Clinical Attachment Level
- Probing Pocket Depth
- Biofilm Control
Interventions
- PROCEDURE
-
MINST + CHX+HA gel
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
MINST is a non-surgical periodontal treatment performed using delicate instrumentation and magnification to selectively remove subgingival biofilm and calculus while minimizing trauma to the soft and hard tissues. The technique aims to preserve gingival architecture, promote stable blood clot formation, and optimize periodontal wound healing in deep periodontal pockets
Sponsors & Collaborators
-
Cairo University
lead OTHER
Principal Investigators
-
Karim Fawzy Elsayed, PhD · Cairo University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-01
- Primary Completion
- 2026-12-10
- Completion
- 2026-12-30
Countries
- Egypt
Study Locations
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