Hyaluronic Acid With Scaling & Root Planing In Chronic Periodontitis Patients With Diabetes Mellitus Type 2

NCT ID: NCT03807596

Last Updated: 2019-01-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-16

Study Completion Date

2017-06-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The present study aimed to assess the adjunctive use of Hyaluronic acid with scaling \& root planing (SRP) in patients with chronic periodontitis \& diabetes mellitus type 2.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Thirty subjects with chronic periodontitis \& diabetes mellitus type 2 were included in this randomized clinical trial. These subjects were randomly allocated into test \& control equal groups. The test group comprised fifteen patients who received SRP with subgingival application of Hyaluronic acid as an adjunct. The control group included fifteen patients who received SRP alone. Plaque index (PI), gingival index (GI), probing depth (PD) \& clinical attachment level (CAL) were measured \& documented at baseline, 6 weeks \& 12 weeks intervals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SRP group

Chronic periodontitis patients with type 2 diabetes mellitus recieved Periodontal treatment in the form of scaling \& root planing (SRP) alone.

Group Type ACTIVE_COMPARATOR

Scaling & root planning alone

Intervention Type PROCEDURE

Patients received full-mouth supra- \& sub-gingival SRP with the use of ultrasonic device \& periodontal universal \& Gracey curettes under local anesthesia.

Hyaluronic acid & SRP group

Chronic periodontitis \& type 2 diabetes mellitus patients received Periodontal treatment in the form of scaling \& root planing (SRP) with the adjunctive use of hyaluronic acid.

Group Type EXPERIMENTAL

Periodontal treatment with Hyaluronic acid associated with SRP

Intervention Type PROCEDURE

In addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Periodontal treatment with Hyaluronic acid associated with SRP

In addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets.

Intervention Type PROCEDURE

Scaling & root planning alone

Patients received full-mouth supra- \& sub-gingival SRP with the use of ultrasonic device \& periodontal universal \& Gracey curettes under local anesthesia.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with chronic periodontitis and type 2 diabetes mellitus
* Minimum of 20 teeth
* Clinical attachment level (CAL) ≥ 3 mm
* Probing depth (PD) ≥ 4 mm.

Exclusion Criteria

* Pregnant females
* Smokers
Minimum Eligible Age

38 Months

Maximum Eligible Age

56 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gihane Gharib Madkour

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gihane G Madkour, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15062011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diabetes and Periodontal Therapy Trial
NCT00997178 COMPLETED PHASE3