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).
- Registration Number
- CTRI/2013/01/003286
- Lead Sponsor
- PRINCIPAL INVESTIGATOR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
a)Patients with presence of systemic conditions or disease affecting bone density e.g. Osteoporosis, Pagetâ??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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To assess the bone regeneration in osseous defects clinically <br/ ><br> <br/ ><br>â?¢To assess the bone regeneration in osseous defects radiographicallyTimepoint: 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 Measures
Name Time Method 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.Timepoint: Recall Appointments at 1 month, 3 month, 6 month & 9 month post surgery intervals for post operative review and clinical and radiological assessment.
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