1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02168543

Enrollment

Registered

2014-06-20

Start date

2009-03-31

Completion date

2011-04-30

Last updated

2014-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

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.

Interventions

DRUGAlendronate

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline plaque scores at 2 month and 6 month	At baseline, 2nd month and 6th month	Plaque scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Change from baseline gingival scores at 2 month and 6 month	At baseline, 2nd month and 6th month	Gingival scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group

Secondary

Measure	Time frame	Description
Change from baseline Probing depth at 2 month and 6 month	At baseline, 2nd month and 6th month	Probing depth assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Change from baseline Periodontal attachment level at 2 month and 6 month	At baseline, 2nd month and 6th month	Periodontal attachment level assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Change from baseline intrabony defect depth at 6 month	At baseline and 6th month	intrabony defect depth assessed at baseline and 6 months for Alendronate and placebo group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026