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1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

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ClinicalTrials.gov Identifier: NCT02168543
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Anuj Sharma, Government Dental College and Research Institute, Bangalore

Brief Summary:
  • Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases new bone formation in chronic periodontitis patients
  • Till date no study has reported the effect of local delivery of ALN in chronic periodontitis patients among smokers. Hence the aim of this study is to investigate the clinical and radiographic effects of locally delivered ALN as an adjunct to the non surgical treatment in smoker chronic periodontitis patients.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Alendronate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Subgingivally Delivered 1% Alendronate in the Treatment of Smokers With Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial.
Study Start Date : March 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : April 2011

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Arm Intervention/treatment
Experimental: Alendronate
1% Alendronate gel once in periodontal pocket (Gums)
Drug: Alendronate
Placebo Comparator: Placebo
Placebo gel once in periodontal pocket (Gums)
Drug: Placebo



Primary Outcome Measures :
  1. Change from baseline plaque scores at 2 month and 6 month [ Time Frame: At baseline, 2nd month and 6th month ]
    Plaque scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group

  2. Change from baseline gingival scores at 2 month and 6 month [ Time Frame: At baseline, 2nd month and 6th month ]
    Gingival scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group


Secondary Outcome Measures :
  1. Change from baseline Probing depth at 2 month and 6 month [ Time Frame: At baseline, 2nd month and 6th month ]
    Probing depth assessed at baseline, at 2 months and 6 months for Alendronate and placebo group

  2. Change from baseline Periodontal attachment level at 2 month and 6 month [ Time Frame: At baseline, 2nd month and 6th month ]
    Periodontal attachment level assessed at baseline, at 2 months and 6 months for Alendronate and placebo group

  3. Change from baseline intrabony defect depth at 6 month [ Time Frame: At baseline and 6th month ]
    intrabony defect depth assessed at baseline and 6 months for Alendronate and placebo group



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Systemically healthy subjects with probing depth (PD) ≥ 5 mm or periodontal attachment level (PAL) ≥ 4 to 6 mm and a radiographical vertical bone loss ≥ 3 mm
  • No history of periodontal therapy in preceding last 6 months
  • No use of antibiotics in the preceding 6 months

Exclusion Criteria:

  • Subjects with known systemic disease
  • Known or suspected allergy to the ALN/bisphosphonate group
  • Those on systemic ALN/bisphosphonate therapy
  • Subjects with aggressive periodontitis,
  • Use of smokeless tobacco in any form,
  • Alcoholics
  • Immunocompromised subjects
  • Pregnant or lactating females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168543


Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore
Investigators
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Principal Investigator: Dr. Anuj Sharma, BDS, MDS RIMS, Ranchi

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Responsible Party: Dr. Anuj Sharma, Anuj Sharma, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02168543     History of Changes
Other Study ID Numbers: GDCRI-09-03
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs