Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets
Primary Purpose
Chronic Periodontitis With Infra-bony Defects
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Hyaluronic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis With Infra-bony Defects focused on measuring Hyaluronic acid, infra-bony defects, chronic periodontitis, experimental, radiographic, clinical, periodontal surgical treatment, open flap curettage
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
Sites / Locations
- Department of Periodontics, University of Damascus Dental School
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Open Curettage Only
Open Curettage with Hyaluronic Acid
Arm Description
patients will be treated by the conventional surgical method, i.e. open curettage without injecting any material.
Hyaluronic Acid injection will be employed in conjunction with the ordinary surgical procedure.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change in the Pocket Probing Depth (PPD)
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.
Buccolingual distance
Buccolingual distance: is the distance between buccal wall and lingual wall of the infra-bony pocket.
Mesiodistal distance
Mesiodistal distance: is the distance between mesial wall and distal wall of the infra-bony pocket.
Depth of infra-bony defect
Depth of infra-bony defect: is the distance between the base of the infra-bony defect and the most coronal level of alveolar crest.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02170857
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis With Infra-bony Defects
Keywords
Hyaluronic acid, infra-bony defects, chronic periodontitis, experimental, radiographic, clinical, periodontal surgical treatment, open flap curettage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Curettage Only
Arm Type
No Intervention
Arm Description
patients will be treated by the conventional surgical method, i.e. open curettage without injecting any material.
Arm Title
Open Curettage with Hyaluronic Acid
Arm Type
Experimental
Arm Description
Hyaluronic Acid injection will be employed in conjunction with the ordinary surgical procedure.
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Intervention Description
This material will be used in conjunction with the ordinary surgical procedure
Primary Outcome Measure Information:
Title
Change in the Clinical Attachment Loss (CAL)
Description
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.
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
Title
Vertical bone fill
Description
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.
Time Frame
at 12 months post-surgery
Secondary Outcome Measure Information:
Title
Change in the Pocket Probing Depth (PPD)
Description
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.
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
Title
Buccolingual distance
Description
Buccolingual distance: is the distance between buccal wall and lingual wall of the infra-bony pocket.
Time Frame
at 12 months post-surgery
Title
Mesiodistal distance
Description
Mesiodistal distance: is the distance between mesial wall and distal wall of the infra-bony pocket.
Time Frame
at 12 months post-surgery
Title
Depth of infra-bony defect
Description
Depth of infra-bony defect: is the distance between the base of the infra-bony defect and the most coronal level of alveolar crest.
Time Frame
at 12 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lina Bashour, DDS MSc
Organizational Affiliation
PhD student, Department of Periodontics, University of Damascus Dental School, Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Razan Khattab, DDS MSc PhD
Organizational Affiliation
Professor of Periodontics, Dean of the Dental School, University of Damascus Dental School, Damascus
Official's Role
Study Director
Facility Information:
Facility Name
Department of Periodontics, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
22238698
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.
Results Reference
background
PubMed Identifier
19277251
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.
Results Reference
background
PubMed Identifier
21187628
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.
Results Reference
background
PubMed Identifier
23444204
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.
Results Reference
background
PubMed Identifier
19537471
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.
Results Reference
background
PubMed Identifier
23055583
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.
Results Reference
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Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets
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