Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets

July 26, 2017 updated by: Damascus University

A Randomized Controlled Trial to Evaluate the Effect of Hyaluronic Acid on Infra-bony Defects: A Radiographic and Clinical Study.

The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of periodontal pockets in people with gum disease.

This research consists of clinical and radiographic studies. Participants should have symmetric periodontal pockets in the upper or lower jaw.

Participants will be treated surgically using hyaluronic acid on one side of the jaw.

Clinical indexes and radiographic cone-beam computed tomographic (CBCT) images will be taken for each participant before surgical treatment and 12 months after surgical treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of infra-bony pockets in chronic periodontitis patients.

This research consists of clinical and radiographic studies.

1- The clinical study: is a randomized controlled trial with a split mouth technique.

Chronic periodontitis patients with Infra-bony pockets will be collected from the Department of Periodontics in faculty of dentistry - Damascus university.

Participants should have symmetric infra-bony pockets in the upper or lower premolar area with pocket probing depth more than 6 mm.

Participants will be treated surgically using open flap curettage.

Open flap curettage will be done for each patient in both sides of the jaw, but hyaluronic acid will be used in one of the two sides with random allocation of the site that in going to be treated with hyaluronic acid.

Plaque index, gingival index, bleeding on probing, tooth mobility index, pocket probing depth and clinical attachment loss will be taken for each participant four times; before surgical treatment, 3 months, six months and 12 months after surgical treatment.

Radiographic study: will be done using CBCT radiography technique. CBCT will be taken for each participant before and after 12 months of surgical treatment. Different distances, vertical bone fill and depth of infra-bony defect will be measured on CBCT images.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Periodontics, University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with chronic periodontitis
  • Symmetric Infra-bony defects with periodontal pocket depth more than 6 mm.
  • in upper or lower premolar area.
  • All participants will be collected from patients attending department of Periodontology - faculty of dentistry for periodontal disease treatment.
  • Males and females.
  • 35-65 years old.
  • Systematically healthy.
  • Accepting to participate in the study. Informed written consent will be required.

Exclusion Criteria:

  • A history of previous scaling and root planning in the last 6 months
  • Smokers
  • Pregnant women
  • Diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Open Curettage Only
patients will be treated by the conventional surgical method, i.e. open curettage without injecting any material.
Experimental: Open Curettage with Hyaluronic Acid
Hyaluronic Acid injection will be employed in conjunction with the ordinary surgical procedure.
Drug: Hyaluronic Acid
This material will be used in conjunction with the ordinary surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Clinical Attachment Loss (CAL)
Time Frame: CAL will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery

Clinical Attachment Loss (CAL): it is the distance between the cement-enamel junction of the tooth and the bottom of the pocket.

CAL will be performed using a dental probe.
CAL will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery
Vertical bone fill
Time Frame: at 12 months post-surgery

Vertical bone fill: it is the distance between the base of the infra-bony defect and cement-enamel junction before surgery minus the distance between base of the infra-bony defect and cement enamel junction after surgery.

It will be measured on CBCT images.
at 12 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Pocket Probing Depth (PPD)
Time Frame: PPD will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery
Pocket Probing Depth (PPD): it is the distance from the gingival margin to the bottom of the pocket at four sites per tooth. PPD will be measured using a dental probe.
PPD will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery
Buccolingual distance
Time Frame: at 12 months post-surgery
Buccolingual distance: is the distance between buccal wall and lingual wall of the infra-bony pocket.
at 12 months post-surgery
Mesiodistal distance
Time Frame: at 12 months post-surgery
Mesiodistal distance: is the distance between mesial wall and distal wall of the infra-bony pocket.
at 12 months post-surgery
Depth of infra-bony defect
Time Frame: at 12 months post-surgery
Depth of infra-bony defect: is the distance between the base of the infra-bony defect and the most coronal level of alveolar crest.
at 12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Lina Bashour, DDS MSc, PhD student, Department of Periodontics, University of Damascus Dental School, Damascus
  • Study Director: Razan Khattab, DDS MSc PhD, Professor of Periodontics, Dean of the Dental School, University of Damascus Dental School, Damascus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Perio-05-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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