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

Innovative Clean-Seal Technique Incorporating Sodium Hypochlorite and Hyaluronic Acid as an Adjunct to Non-Invasive Therapy for Stage III Periodontitis Management

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontitis (Stage 3)
• Intervention / Treatment: Other: Scaling and root planing with sodium hypochlorite and hyaluronic acid; Procedure: Scaling and root planing

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Scaling and root planing	Procedure: Scaling and root planing; Pockets were treated with sub-gingival scalling and root planning alone.
Experimental: Scaling and root planing with sodium hypochlorite and hyaluronic acid	Other: Scaling and root planing with sodium hypochlorite and hyaluronic acid; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth	Probing Depth is the measurement of the distance from the gingival margin to the bottom of the periodontal pocket using a periodontal probe. Values typically range from 1-3 mm (healthy) to ≥5 mm (indicative of periodontal disease), with deeper pockets reflecting more severe attachment loss.	up to 12 weeks
Clinical attachment loss	Clinical Attachment Loss measures the distance from the cementoenamel junction to the base of the periodontal pocket, indicating the extent of periodontal support lost. Values range from 0 mm (no attachment loss) to ≥5 mm or more (severe loss), with higher measurements reflecting greater periodontal destruction.	up to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological assessment of P. gingivalis	The bacteriological parameter by using Real Time PCR was used to evaluate the Porphyromonas gingivalis load. Sub-gingival plaque samples were taken by removing of the supra-gingival plaque with curette and cotton pellets before inserting , sterile endodontic paper points in periodontal pocket and leaving them in situ for 10 seconds. The paper points were immediately transferred to sterile , dry cryovials . Paper points were stored frozen at -80 ºC immediately after sample collection until being processed with PCR.	6 weeks

Collaborators and Investigators

• Sponsor: Karim Ismail

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): January 10, 2024
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: July 8, 2025
• First Submitted That Met QC Criteria: July 8, 2025
• First Posted (Actual): July 17, 2025

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Disinfectants; Hyaluronic Acid; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: 9208891

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No