Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Periodontitis With Infra-bony Defects

Intervention / Treatment
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* Drug: Hyaluronic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Clinical Attachment Loss (CAL) | 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 | 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) | 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 | Buccolingual distance: is the distance between buccal wall and lingual wall of the infra-bony pocket. | at 12 months post-surgery | 
| Mesiodistal distance | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic acid, infra-bony defects, chronic periodontitis, experimental, radiographic, clinical, periodontal surgical treatment, open flap curettage