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NCT Number: NCT02170857

Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets

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.

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Key information

Conditions

Chronic Periodontitis With Infra-bony Defects Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid

Drug

This material will be used in conjunction with the ordinary surgical procedure

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 23, 2014
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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