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Trial record 1 of 1 for:    Nct02170857,2014
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Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets

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ClinicalTrials.gov Identifier: NCT02170857
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis With Infra-bony Defects Drug: Hyaluronic Acid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Evaluate the Effect of Hyaluronic Acid on Infra-bony Defects: A Radiographic and Clinical Study.
Study Start Date : June 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2017


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170857


Locations
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Syrian Arab Republic
Department of Periodontics, University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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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:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02170857    
Other Study ID Numbers: UDDS-Perio-05-2014
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Keywords provided by Damascus University:
Hyaluronic acid
infra-bony defects
chronic periodontitis
experimental
radiographic
clinical
periodontal surgical treatment
open flap curettage
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents