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

NCT ID: NCT03043066

Last Updated: 2017-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2016-10-01

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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group A - scaling and root planing Group B - scaling and root planing along with antibiotic intervention of amoxicillin and metronidazole
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A -control group

15 subjects underwent scaling and root planing

Group Type PLACEBO_COMPARATOR

Scaling and root planing

Intervention Type PROCEDURE

subjects underwent full mouth supragingival and subgingival scaling

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

Group Type ACTIVE_COMPARATOR

scaling and root planing along with antibiotic intervention

Intervention Type DRUG

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

Interventions

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Scaling and root planing

subjects underwent full mouth supragingival and subgingival scaling

Intervention Type PROCEDURE

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

Intervention Type DRUG

Other Intervention Names

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Non-surgical periodontal therapy Systemic antibiotics

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meenakshi Ammal Dental College and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr.Jaideep Mahendra

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandhya CH, BDS

Role: PRINCIPAL_INVESTIGATOR

Meenakshi Ammal Dental College & Hospital

References

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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.

Reference Type BACKGROUND
PMID: 27027501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25142259 (View on PubMed)

Other Identifiers

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MADC/IRB-IX/2016/193

Identifier Type: -

Identifier Source: org_study_id

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