CTRI Number |
CTRI/2013/01/003286 [Registered on: 04/01/2013] Trial Registered Retrospectively |
Last Modified On: |
03/01/2013 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Non-randomized, Placebo Controlled Trial |
Public Title of Study
|
CLINICAL AND RADIOGRAPHIC ASSESSMENT OF BONE REGENERATION USING ALENDRONATE SODIUM GEL IN CHRONIC PERIODONTITIS (an inflammatory condition affecting the tissues that surround and support the teeth). |
Scientific Title of Study
|
CLINICAL AND RADIOGRAPHIC ASSESSMENT OF BONE REGENERATION USING ALENDRONATE SODIUM GEL AS AN
ADJUNCT TO SURGICAL THERAPY FOR THE TREATMENT OF OSSEOUS DEFECTS IN CHRONIC PERIODONTITIS- A COMPARATIVE STUDY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
MAJ DR MUNISHWAR SINGH |
Designation |
PG Resident |
Affiliation |
Armed Forces Medical College |
Address |
Division of Periodontology
Department of Dental Surgery
Armed Forces Medical College
Wanowrie
Pune
Pune MAHARASHTRA 411040 India |
Phone |
7875444846 |
Fax |
|
Email |
msmalhi@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
COL Dr PK GARG |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
Armed Forces Medical College |
Address |
Division of Periodontology
Department of Dental Surgery
Armed Forces Medical College
Wanowrie
Pune
Pune MAHARASHTRA 411040 India |
Phone |
7875444846 |
Fax |
|
Email |
colpkgarg@gmail.com |
|
Details of Contact Person Public Query
|
Name |
MAJ DR MUNISHWAR SINGH |
Designation |
PG Resident |
Affiliation |
Armed Forces Medical College |
Address |
Division of Periodontology
Department of Dental Surgery
Armed Forces Medical College
Wanowrie
Pune
Pune MAHARASHTRA 411040 India |
Phone |
7875444846 |
Fax |
|
Email |
msmalhi@yahoo.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
PRINCIPAL INVESTIGATOR |
Address |
Division of Periodontology,
Department of Dental surgery,
Armed Forces Medical College,
Wanowrie
Pune |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
MAJ MUNISHWAR SINGH |
AFMC |
Division of Periodontology,
Department of Dental Surgery,
Armed Forces Medical College,
Wanowrie, Pune MAHARASHTRA |
7875444846
msmalhi@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Maharashtra University of Health Sciences Committee |
Approved |
Medical Research Cell and Institutional Ethical Committee, Armed Forces Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Clinical diagnosis of moderate generalized chronic periodontitis with Periodontal probing depth ≥5 mm or clinical attachment loss 4 to 6 mm bilaterally and vertical bone loss 5mm on IOPAR. |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
0.1 ml (200µg)Alendronate Gel |
At the experimental site, 0.1 ml (200µg) of Alendronate gel will be delivered to the osseous defect while the control site will receive 0.1 ml of Placebo, alendronate-free gel with identical basic composition.
The gel is to be prepared as per the following article; Reddy GT, Kumar PM, Veena KM. Formulation and evaluation of Alendronate sodium gel for the treatment of bone resorptive lesions in periodontitis. Drug Delivery 2005; 12: 217-222. |
Comparator Agent |
0.1 ml of Placebo, alendronate-free gel with identical basic composition. |
At the experimental site, 0.1 ml (200µg) of Alendronate gel will be delivered to the osseous defect while the control site will receive 0.1 ml of Placebo, alendronate-free gel with identical basic composition. The gel is to be prepared as per the following article; Reddy GT, Kumar PM, Veena KM. Formulation and evaluation of Alendronate sodium gel for the treatment of bone resorptive lesions in periodontitis. Drug Delivery 2005; 12: 217-222. |
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
a)Patient of either sex within the age group of 35-50 years.
b)Systemically healthy patients.
c)Clinical diagnosis of moderate generalized chronic periodontitis.
d)Patients with probing depth ≥5 mm or clinical attachment loss > 4 to 6 mm bilaterally as evidenced by clinical examination.
e)Patients with vertical bone loss > 5mm as evidenced on IOPA radiograph.
f)Patients with acceptable oral hygiene following Phase-I therapy. |
|
ExclusionCriteria |
Details |
a)Patients with presence of systemic conditions or disease affecting bone density e.g. Osteoporosis, Paget’s disease.
b)Patients with known or suspected allergy to Alendronate/ bisphosphonates group.
c)Patients with Aggressive Periodontitis.
d)Patients with horizontal bone loss.
e)Patients without any contradictions for periodontal surgery.
f)Patients with a history of drug intake that can affect bone metabolism in the past 6 months. E.g. NSAIDs.
g)Patients who are current smokers, or ex smokers for less than five years.
h)Pregnant or lactating females.
i)Patients who are alcoholics.
j)Immunocompromised patients.
k)Patients using tobacco in any form.
l)Patients with gross oral pathology, tumors which can alter the course of periodontal
disease.
m)Patients who have taken medications affecting periodontal status or has received periodontal therapy in the preceding six months. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
•To assess the bone regeneration in osseous defects clinically
•To assess the bone regeneration in osseous defects radiographically |
Recall Appointments at 1 month, 3 month, 6 month & 9 month post surgery intervals for post operative review and clinical and radiological assessment. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Baseline clinical parameters like Bleeding on Probing, Gingival Index, Periodontal Probing Depth and Clinical Attachment Level of all the patients will be measured followed by radiographic assessment by intra-oral radiograph. |
Recall Appointments at 1 month, 3 month, 6 month & 9 month post surgery intervals for post operative review and clinical and radiological assessment. |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
12/07/2012 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="9" Days="17" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NOT PUBLISHED |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Periodontitis is one of the major causes of tooth loss in the world. It encompasses multifactorial diseases involving bacterial biofilms and generation of an inflammatory response including the production of cytokines and matrix metalloproteinases.
For many years, the major focus of periodontal research has been directed towards the reduction or elimination of pathogenic bacteria that are thought to cause periodontitis. This has been accomplished in a large part by the use of mechanical treatment approaches like scaling and root planning, use of home care measures and finally surgical intervention. In recent years, other adjunctive approaches that aim to eradicate or reduce the periodontal disease initiation or progression have included pharmacologic measures with the use of systemic and/or local anti-microbial therapies.
Even when periodontal diseases are controlled or cured, the patients are often left with an anatomical evidence of the disease, including loss of bone and periodontal support for their remaining teeth. Therefore, newer approaches are being developed to stimulate regeneration of lost periodontal tissues.
Apart from periodontal therapy directed towards regeneration, it appears that most treatments available today are directed towards reduction or elimination of exogenous factors that might cause or exacerbate periodontal diseases. There is still an increasing body of evidence suggesting that various approaches which involve host modulation might also be helpful in the management of periodontitis and its sequelae.
Three potential approaches to host modulation therapy have been considered: 1) inhibition of matrix metalloproteinases with antiproteinases,e.g. tetracyclines. 2) blocking production of pro-inflammatory cytokines and prostaglandins with anti-inflammatory drugs, e.g. NSAIDs: aspirin, ibuprofen, naproxen. and 3) inhibiting activation of osteoclasts with bone sparing agents e.g. bisphosphonates: Alendronate.
The bisphosphonates are synthetic biochemical modifiers of bone resorption. The bisphosphonates are widely used in the management of systemic metabolic bone diseases due to their ability to inhibit bone resorption. Given their known affinity to bone, ability to increase osteoblastic differentiation and to inhibit osteoclast recruitment and activity; there exists a possible use for bisphosphonates in the diagnostic and management of periodontal diseases.
Among Bisphosphonates, Alendronate Sodium has been found to be very effective in inhibition of bone resorption. When given systemically in patients with periodontal disease, Alendronate can significantly reduce alveolar bone resorption and cause an improvement in the height of the crestal bone.
Though the systemic use of bisphosphonates, including etidronate, alendronate, pamidronate and risedronate, can lead to reduced bone turnover, increased bone mass and improved mineralization, studies have shown similar promising results with the local use of bisphosphonates.
Studies have shown that systemically administered bisphosphonates can induce gastrointestinal disturbances such as esophagitis, erosions, and ulcerations. Local drug application avoids most of these problems, by limiting the drug to the target site (site specific approach) with little or no systemic uptake. Also, the local concentration achieved can be much higher (100 folds) than that via systemic route.
Thus, the present study aims to evaluate clinically and radiographically the efficacy of local application of 1% Alendronate Sodium gel as anadjunct to surgical therapy in the treatment of osseous bone defects in patients with chronic periodontitis. |