1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

Chronic Periodontitis Clinical Trial

Official title:

Clinical Efficacy of Subgingivally Delivered 1% Alendronate in the Treatment of Smokers With Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168543
• Other study ID #: GDCRI-09-03
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2014
• Last updated: June 18, 2014
• Start date: March 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2014
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Alendronate

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline plaque scores at 2 month and 6 month	Plaque scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group	At baseline, 2nd month and 6th month
Primary	Change from baseline gingival scores at 2 month and 6 month	Gingival scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group	At baseline, 2nd month and 6th month
Secondary	Change from baseline Probing depth at 2 month and 6 month	Probing depth assessed at baseline, at 2 months and 6 months for Alendronate and placebo group	At baseline, 2nd month and 6th month
Secondary	Change from baseline Periodontal attachment level at 2 month and 6 month	Periodontal attachment level assessed at baseline, at 2 months and 6 months for Alendronate and placebo group	At baseline, 2nd month and 6th month
Secondary	Change from baseline intrabony defect depth at 6 month	intrabony defect depth assessed at baseline and 6 months for Alendronate and placebo group	At baseline and 6th month