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

NCT ID: NCT07071467

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontitis (Stage 3) Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Scaling and root planing with sodium hypochlorite and hyaluronic acid

Group Type EXPERIMENTAL

Scaling and root planing with sodium hypochlorite and hyaluronic acid

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Scaling and root planing

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type OTHER

Scaling and root planing

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karim Ismail

OTHER

Sponsor Role lead

Responsible Party

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Karim Ismail

MSc. candidate in the diagnosis, oral medicine & periodontology department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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9208891

Identifier Type: -

Identifier Source: org_study_id

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