Serum TRAP-5b Levels in Patients With Generalized Chronic Periodontitis

Study Overview
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Brief Summary
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To compare the effect of non-surgical periodontal therapy with or without systemic administration of amoxicillin and metronidazole on the concentration of serum levels of TRAP-5b in patients with generalized chronic periodontitis.

Detailed Description
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30 Chronic periodontitis subjects were divided into two groups- group A underwent scaling and root planing and group B underwent scaling and root planing with systemic administration of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days. Periodontal parameters probing pocket depth and clinical attachment level were measured at baseline and at 3rd month. Serum TRAP-5b levels were also measured at baseline, 1 month and at 3rd month.

Official Title
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The Effect of Non-surgical Periodontal Therapy With or Without Systemic Administration of Amoxicillin and Metronidazole on Serum Levels of TRAP-5b in Patients With Generalized Chronic Periodontitis - A Comparative Clinical Study

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Procedure: Scaling and root planing
* Drug: scaling and root planing along with antibiotic intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of atleast 20 teeth more than 30% of sites with clinical attachment loss of ≥ 5 mm non-smokers no previous history of periodontal therapy Exclusion Criteria: systemic diseases under antibiotics or anti-inflammatory drugs within previous 3 months pregnant and lactating women allergic to antibiotics

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

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
Interventional Model Description: Group A - scaling and root planing Group B - scaling and root planing along with antibiotic intervention of amoxicillin and metronidazole
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A -control group<br>15 subjects underwent scaling and root planing | Procedure: Scaling and root planing<br>* subjects underwent full mouth supragingival and subgingival scaling<br>* Other names: Non-surgical periodontal therapy;|
| Active Comparator: Group B-Interventional group<br>15 subjects underwent scaling and root planing along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days | Drug: scaling and root planing along with antibiotic intervention<br>* subjects underwent full mouth supragingival and subgingival scaling along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days<br>* Other names: Systemic antibiotics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of TRAP-5b | Concentration of serum levels of TRAP-5b was assessed at baseline and at 3rd month using ELISA method. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth | Probing pocket depth was measured using Williams periodontal probe at baseline and at 3rd month | Baseline and 3 months | 
| Clinical attachment level | Clinical attachment level was measured as a distance between base of pocket and a fixed point on the crown, such as cemento-enamel junction at baseline and at 3rd month. | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Periodontitis, TRAP-5b, Non-surgical periodontal therapy, Systemic antibiotics