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Completed

NCT Number: NCT07071467

Testing 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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. Plaque accumulation

    Time frame: up to 12 weeks

    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.

  2. Gingival condition assessment

    Time frame: up to 12 weeks

    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.

Secondary outcomes

  1. Probing depth

    Time frame: up to 12 weeks

    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.

  2. Clinical attachment loss

    Time frame: up to 12 weeks

    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.

Other outcomes

  1. Microbiological assessment of P. gingivalis

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Karim Ismail

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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