Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets

NCT02170857 | Completed DMC

• 1 other identifier: UDDS-Perio-05-2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis With Infra-bony Defects

Keywords

Hyaluronic acid; infra-bony defects; chronic periodontitis; experimental; radiographic; clinical; periodontal surgical treatment; open flap curettage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in the Pocket Probing Depth (PPD)

  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

  at 12 months post-surgery

• Mesiodistal distance

  at 12 months post-surgery

• Depth of infra-bony defect

  at 12 months post-surgery

Study Arms (2)

Open Curettage Only

NO INTERVENTION

patients will be treated by the conventional surgical method, i.e. open curettage without injecting any material.

Open Curettage with Hyaluronic Acid

EXPERIMENTAL

Hyaluronic Acid injection will be employed in conjunction with the ordinary surgical procedure.

Drug: Hyaluronic Acid

Interventions

Hyaluronic Acid DRUG

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

Open Curettage with Hyaluronic Acid

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years old.
• Systematically healthy.
• Accepting to participate in the study. Informed written consent will be required.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Periodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (6)

• Baldini A, Zaffe D, Nicolini G. Bone-defects healing by high-molecular hyaluronic acid: preliminary results. Ann Stomatol (Roma). 2010 Jan;1(1):2-7. Epub 2010 Jun 29.

  PMID: 22238698 BACKGROUND

• Ballini A, Cantore S, Capodiferro S, Grassi FR. Esterified hyaluronic acid and autologous bone in the surgical correction of the infra-bone defects. Int J Med Sci. 2009;6(2):65-71. doi: 10.7150/ijms.6.65. Epub 2009 Feb 26.

  PMID: 19277251 BACKGROUND

• Bansal J, Kedige SD, Anand S. Hyaluronic acid: a promising mediator for periodontal regeneration. Indian J Dent Res. 2010 Oct-Dec;21(4):575-8. doi: 10.4103/0970-9290.74232.

  PMID: 21187628 BACKGROUND

• Briguglio F, Briguglio E, Briguglio R, Cafiero C, Isola G. Treatment of infrabony periodontal defects using a resorbable biopolymer of hyaluronic acid: a randomized clinical trial. Quintessence Int. 2013 Mar;44(3):231-40. doi: 10.3290/j.qi.a29054.

  PMID: 23444204 BACKGROUND

• Vanden Bogaerde L. Treatment of infrabony periodontal defects with esterified hyaluronic acid: clinical report of 19 consecutive lesions. Int J Periodontics Restorative Dent. 2009 Jun;29(3):315-23.

  PMID: 19537471 BACKGROUND

• Gontiya G, Galgali SR. Effect of hyaluronan on periodontitis: A clinical and histological study. J Indian Soc Periodontol. 2012 Apr;16(2):184-92. doi: 10.4103/0972-124X.99260.

  PMID: 23055583 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Lina Bashour, DDS MSc

  PhD student, Department of Periodontics, University of Damascus Dental School, Damascus

  PRINCIPAL INVESTIGATOR

• Razan Khattab, DDS MSc PhD

  Professor of Periodontics, Dean of the Dental School, University of Damascus Dental School, Damascus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

SY (1)