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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: Scaling and root planing; Drug: scaling and root planing along with antibiotic intervention

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A -control group; 15 subjects underwent scaling and root planing	Procedure: Scaling and root planing; subjects underwent full mouth supragingival and subgingival scaling; Other Names: Non-surgical periodontal therapy
Active Comparator: Group B-Interventional group; 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; 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; Other Names: Systemic antibiotics

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meenakshi Ammal Dental College and Hospital
• Investigators: Principal Investigator: Sandhya CH, BDS, Meenakshi Ammal Dental College & Hospital

Publications and helpful links

General Publications

• Keestra JA, Grosjean I, Coucke W, Quirynen M, Teughels W. Non-surgical periodontal therapy with systemic antibiotics in patients with untreated chronic periodontitis: a systematic review and meta-analysis. J Periodontal Res. 2015 Jun;50(3):294-314. doi: 10.1111/jre.12221. Epub 2014 Aug 21.
• Cosgarea R, Juncar R, Heumann C, Tristiu R, Lascu L, Arweiler N, Stavropoulos A, Sculean A. Non-surgical periodontal treatment in conjunction with 3 or 7 days systemic administration of amoxicillin and metronidazole in severe chronic periodontitis patients. A placebo-controlled randomized clinical study. J Clin Periodontol. 2016 Sep;43(9):767-77. doi: 10.1111/jcpe.12559. Epub 2016 Jun 23.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): July 31, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 28, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Periodontitis; Non-surgical periodontal therapy; TRAP-5b; Systemic antibiotics
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: MADC/IRB-IX/2016/193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No