Bone Resorption, Periodontitis
Conditions
Brief summary
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.
Interventions
DRUGSodium 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
OTHERPlacebo
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
Sponsors
Pontifícia Universidade Católica de Minas Gerais
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pocket depth | baseline and 3- and to 6-month evaluations | Reductions in pocket depth overtime |
| Changes in clinical attachment level | baseline and 3- and to 6-month evaluations | Gain in clinical attachment level overtime |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in bone defects | Baseline and 6 months | Reduction in bone defects by bone filling |
Countries
Brazil
Outcome results
None listed