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

Not Applicable

Completed

• Conditions: Chronic Periodontitis
• Interventions: Procedure: Scaling and root planing; Drug: scaling and root planing along with antibiotic intervention

• Registration Number: NCT03043066
• Lead Sponsor: Meenakshi Ammal Dental College and Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2016-07-31
• Study Completion: 2016-10-01
• Status Verified: 2017-01
• Study First Submitted: 2017-01-28
• Study First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Study First Posted: 2017-02-03
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A -control group	Scaling and root planing	15 subjects underwent scaling and root planing
Group B-Interventional group	scaling and root planing along with antibiotic intervention	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

Primary Outcome Measures

Name	Time	Method
Serum levels of TRAP-5b	Baseline and 3 months	Concentration of serum levels of TRAP-5b was assessed at baseline and at 3rd month using ELISA method.

Secondary Outcome Measures

Name	Time	Method
Clinical attachment level	Baseline and 3 months	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.
Probing pocket depth	Baseline and 3 months	Probing pocket depth was measured using Williams periodontal probe at baseline and at 3rd month