1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: Alendronate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02168543

GDCRI-09-03

Details and patient eligibility

About

• 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.

Enrollment: 46 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Alendronate

Experimental group

Description:

1% Alendronate gel once in periodontal pocket (Gums)

Treatment:

Drug: Alendronate

Placebo

Placebo Comparator group

Description:

Placebo gel once in periodontal pocket (Gums)

Treatment:

Drug: Placebo