Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets

NCT ID: NCT02170857

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-02-28

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.

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.

Conditions

Chronic Periodontitis With Infra-bony Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Open Curettage Only

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Open Curettage with Hyaluronic Acid

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

Group Type: EXPERIMENTAL

Hyaluronic Acid

Intervention Type: DRUG

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

Interventions

Hyaluronic Acid

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lina Bashour, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

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

Razan Khattab, DDS MSc PhD

Role: STUDY_DIRECTOR

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

Locations

Department of Periodontics, University of Damascus Dental School

Damascus, , Syria

Countries

Syria

References

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.

Reference Type: BACKGROUND

PMID: 22238698 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19277251 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21187628 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23444204 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19537471 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23055583 (View on PubMed)

Other Identifiers

UDDS-Perio-05-2014

Identifier Type: -

Identifier Source: org_study_id