Sodium Alendronate in Non Surgical Periodontal Therapy

Study Overview
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Brief Summary
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In the past few years, studies have evaluated the effect of systemic use of sodium alendronate, especially in the treatment of structural bone defects caused by periodontal diseases. This study evaluated the effects of non-surgical periodontal treatment associated with the topical application of 1% sodium alendronate on clinical and topographical parameters. Chronic periodontitis patients were recruited for the present study and were monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.

Official Title
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Effects of 1% Sodium Alendronate in Non Surgical Periodontal Therapy on Clinical and Tomographical Parameters: a Randomized Placebo Controlled 6-month Clinical Trial

Conditions
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Periodontitis, Bone Resorption

Intervention / Treatment
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* Drug: Sodium alendronate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic periodontitis two contralateral teeth showing periodontal pocket depth ≥ 5mm, clinical attachment loss > 3mm, proximal vertical bone defects, no prosthetic device, without caries lesions, proximal dental contact and lack of premature occlusal contact systemically healthy volunteers Exclusion Criteria: need for antibiotic or systemic/local antibiotic use in the previous 3 months periodontal treatment in the previous 6 months pregnancy or lactation immunological disorders or imune suppressive treatments diabetes smoking orthodontic appliances or removable prosthesis osteoporosis known or suspected allergy to biphosphonates systemic use of biphosphonates

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Alendronate<br>Adjunctive use of 1% sodium alendronate gel as part of periodontitis treatment | Drug: Sodium alendronate<br>* After manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth ≥ 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% sodium alendronate gel<br>* Other names: biphosphonates;|
| Placebo Comparator: Placebo<br>Adjunctive use of placebo gel as part of periodontitis treatment | Other: Placebo<br>* After manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth ≥ 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% placebo gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pocket depth | Reductions in pocket depth overtime | baseline and 3- and to 6-month evaluations | 
| Changes in clinical attachment level | Gain in clinical attachment level overtime | baseline and 3- and to 6-month evaluations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone defects | Reduction in bone defects by bone filling | Baseline and 6 months |