The Impact of Obesity on Nonsurgical Periodontal Therapy

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect that obesity may have on the nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive periodontal diseases (chronic periodontitis).

Detailed Description
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Normal weight (BMI 18.5-24.9 kg/m2) and obese (BMI >30 kg/m2) women will be randomly assigned to two nonsurgical periodontal treatments: scaling and root planing + placebo scaling and root planing + metronidazole

Official Title
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The Impact of Obesity on Nonsurgical Periodontal Treatment of Destructive Periodontal Diseases

Conditions
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Periodontitis, Periodontal Diseases, Obesity

Intervention / Treatment
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* Drug: Metronidazole
* Drug: Placebo
* Procedure: Scaling and root planning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal weight or obese (according to BMI) nonsmokers or former smokers (3 or more years) no systemic diseases that may affect periodontal treatment (diabetes, osteoporosis, steroid use) have 10 teeth present have at least 2 teeth with probing depth 6+mm and attachment loss 4+mm Exclusion Criteria: Pregnancy Development of diabetes or other conditions that may impair periodontal healing

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Metronidazole<br> | Drug: Metronidazole<br>* Metronidazole 400mg TID for 10 days<br>* Other names: Flagyl;Procedure: Scaling and root planning<br>* Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia<br>* Other names: Nonsurgical periodontal therapy;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo pill TID for 10 days<br>* Other names: Inactive Drug;Procedure: Scaling and root planning<br>* Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia<br>* Other names: Nonsurgical periodontal therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Defined as the distance from the free gingival margin to the bottom of the pocket/sulcus. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attachment level | Defined as the distance from the CEJ to the bottom of the pocket/sulcus. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Periodontal diseases, Obesity, Metronidazole, Prognosis, Probing depth, Periodontal attachment loss