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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  
SELF FINANCED 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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