Sodium Alendronate in Non Surgical Periodontal Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-11-30

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.

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Detailed Description

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Conditions

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Periodontitis Bone Resorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sodium Alendronate

Adjunctive use of 1% sodium alendronate gel as part of periodontitis treatment

Group Type EXPERIMENTAL

Sodium alendronate

Intervention Type DRUG

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

Placebo

Adjunctive use of placebo gel as part of periodontitis treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Sodium alendronate

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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biphosphonates

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Bernardo de Carvalho Dutra

Clinical evaluation and treatment for the effect of image periodontal mechanical non surgical associated with application of topical alendronate sodium a 1% repair periodontal: randomized controlled clinical trial

Responsibility Role PRINCIPAL_INVESTIGATOR