Testing Sodium Hypochlorite and Hyaluronic Acid as an Adjunct to Non-Invasive Therapy for Stage III Periodontitis Management

NCT07071467 | Completed

• 1 other identifier: 9208891
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study was designed to evaluate the concept of the clean \& seal, using sodium hypochlorite gel and hyaluronic acid as adjunctive to non-surgical therapy for management of Stage III Periodontitis.

Conditions

Periodontitis (Stage 3); Periodontitis

Outcome Measures

Primary Outcomes (2)

• Plaque accumulation

  This was assessed using O'Leary plaque index. The O'Leary Plaque Index records the presence or absence of dental plaque on four surfaces (mesial, distal, buccal, lingual) of each tooth. The score ranges from 0% (no plaque) to 100% (plaque on all surfaces), with lower percentages indicating better oral hygiene.

  up to 12 weeks

• Gingival condition assessment

  The Gingival Index of Löe and Silness was used to assess the severity of gingival inflammation based on color, consistency, and bleeding on probing across four areas per tooth. Scores range from 0 (normal gingiva) to 3 (severe inflammation with spontaneous bleeding), with higher scores indicating worse gingival health.

  up to 12 weeks

Secondary Outcomes (2)

• Probing depth

  up to 12 weeks

• Clinical attachment loss

  up to 12 weeks

Other Outcomes (1)

• Microbiological assessment of P. gingivalis

  6 weeks

Study Arms (2)

Scaling and root planing with sodium hypochlorite and hyaluronic acid

EXPERIMENTAL

Other: Scaling and root planing with sodium hypochlorite and hyaluronic acid

Scaling and root planing

ACTIVE COMPARATOR

Procedure: Scaling and root planing

Interventions

Scaling and root planing with sodium hypochlorite and hyaluronic acid OTHER

Sodium hypochlorite gel was applied first for 30 seconds, then followed by subgingival instrumentation of the site. Then, 1.8% hyaluronic acid (1.6% cross-linked, 0.2% natural hyaluronic acid ) was applied subgingivally into the periodontal pocket to seal the site.

Scaling and root planing with sodium hypochlorite and hyaluronic acid

Scaling and root planing PROCEDURE

Pockets were treated with sub-gingival scalling and root planning alone.

Scaling and root planing

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes diagnosed with periodontitis Stage III.
• CAL ≥ 5mm or bone loss affecting middle third of the root in more than two adjacent teeth.
• PPD ≥ 6mm in more than two adjacent teeth.
• Periodontal tooth loss ≤ 4 teeth.
• Systemically healthy patients.

You may not qualify if:

• Patient with uncontrolled diabetes.
• Pregnant or lactating.
• Tobacco smoker ≥ 10 cigarettes/day.
• Antibiotic treatment within previous 4 weeks.
• Acute periodontal or periapical abscess

Sponsors & Collaborators

• Karim Ismail: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing; Sodium Hypochlorite; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc. candidate in the diagnosis, oral medicine & periodontology department

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: September 1, 2023
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

EG (1)