Faculty of Dentistry, Alexandria University
Alexandria, Egypt
NCT Number: NCT07071467
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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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Alexandria, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Pockets were treated with sub-gingival scalling and root planning alone.
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.
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.
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.
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.
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.
Karim Ismail
Other
Innovative Clean-Seal Technique Incorporating Sodium Hypochlorite and Hyaluronic Acid as an Adjunct to Non-Invasive Therapy for Stage III Periodontitis Management
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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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