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Completed

NCT Number: NCT02168543

1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

* 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.

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Key information

Conditions

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

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alendronate

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2014
Registry last updated
Jun 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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