Clinical trial NCT02170857: Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets
Official title: A Randomized Controlled Trial to Evaluate the Effect of Hyaluronic Acid on Infra-bony Defects: A Radiographic and Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis With Infra-bony Defects
Keywords: Hyaluronic acid
infra-bony defects
chronic periodontitis
experimental
radiographic
clinical
periodontal surgical treatment
open flap curettage
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the Clinical Attachment Loss (CAL)
timeFrame: 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
measure: Vertical bone fill
timeFrame: at 12 months post-surgery
Secondary outcomes:
measure: Change in the Pocket Probing Depth (PPD)
timeFrame: 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
measure: Buccolingual distance
timeFrame: at 12 months post-surgery
measure: Mesiodistal distance
timeFrame: at 12 months post-surgery
measure: Depth of infra-bony defect
timeFrame: at 12 months post-surgery
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Periodontics, University of Damascus Dental School
Study officials:
affiliation: PhD student, Department of Periodontics, University of Damascus Dental School, Damascus
name: Lina Bashour, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Periodontics, Dean of the Dental School, University of Damascus Dental School, Damascus
name: Razan Khattab, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.