1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

NCT02168543 | Completed Phase 2 DMC

• 1 other identifier: GDCRI-09-03
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Change from baseline Probing depth at 2 month and 6 month

  At baseline, 2nd month and 6th month

• Change from baseline Periodontal attachment level at 2 month and 6 month

  At baseline, 2nd month and 6th month

• Change from baseline intrabony defect depth at 6 month

  At baseline and 6th month

Study Arms (2)

Alendronate

EXPERIMENTAL

1% Alendronate gel once in periodontal pocket (Gums)

Drug: Alendronate

Placebo

PLACEBO COMPARATOR

Placebo gel once in periodontal pocket (Gums)

Drug: Placebo

Interventions

Alendronate DRUG

Alendronate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Dr. Anuj Sharma, BDS, MDS

  RIMS, Ranchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anuj Sharma

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 20, 2014
• Study Start: March 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 20, 2014

Record last verified: 2014-06