Overview

This trial is active, not recruiting.

Condition chronic periodontitis with infra-bony defects
Treatment hyaluronic acid
Sponsor Damascus University
Start date June 2014
End date February 2016
Trial size 30 participants
Trial identifier NCT02170857, UDDS-Perio-05-2014

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(No Intervention)
patients will be treated by the conventional surgical method, i.e. open curettage without injecting any material.
(Experimental)
Hyaluronic Acid injection will be employed in conjunction with the ordinary surgical procedure.
hyaluronic acid
This material will be used in conjunction with the ordinary surgical procedure

Primary Outcomes

Measure
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
Vertical bone fill
time frame: at 12 months post-surgery

Secondary Outcomes

Measure
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
Buccolingual distance
time frame: at 12 months post-surgery
Mesiodistal distance
time frame: at 12 months post-surgery
Depth of infra-bony defect
time frame: at 12 months post-surgery

Eligibility Criteria

Male or female participants from 35 years up to 65 years old.

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

Additional Information

Official title A Randomized Controlled Trial to Evaluate the Effect of Hyaluronic Acid on Infra-bony Defects: A Radiographic and Clinical Study.
Principal investigator Lina Bashour, DDS MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Damascus University.