Chronic Periodontitis With Infra-bony Defects Clinical Trial
Official title:
A Randomized Controlled Trial to Evaluate the Effect of Hyaluronic Acid on Infra-bony Defects: A Radiographic and Clinical Study.
| Verified date | July 2017 |
| Source | Damascus University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | February 2017 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 35 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Syrian Arab Republic | Department of Periodontics, University of Damascus Dental School | Damascus |
| Lead Sponsor | Collaborator |
|---|---|
| Damascus University |
Syrian Arab Republic,
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. — View 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. Epub 2009 Feb 26. — View 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. Review. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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. | 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 | |
| Secondary | Buccolingual distance | Buccolingual distance: is the distance between buccal wall and lingual wall of the infra-bony pocket. | at 12 months post-surgery | |
| Secondary | Mesiodistal distance | Mesiodistal distance: is the distance between mesial wall and distal wall of the infra-bony pocket. | at 12 months post-surgery | |
| Secondary | 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. | at 12 months post-surgery |