NCT03043066

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
Last Updated

February 3, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

January 28, 2017

Last Update Submit

February 1, 2017

Conditions

Chronic Periodontitis

Keywords

Chronic PeriodontitisTRAP-5bNon-surgical periodontal therapySystemic antibiotics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Probing pocket depth

    Baseline and 3 months

  • Clinical attachment level

    Baseline and 3 months

Study Arms (2)

Group A -control group

PLACEBO COMPARATOR

15 subjects underwent scaling and root planing

Procedure: Scaling and root planing

Group B-Interventional group

ACTIVE COMPARATOR

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

Interventions

Scaling and root planingPROCEDURE

subjects underwent full mouth supragingival and subgingival scaling

Also known as: Non-surgical periodontal therapy
Group A -control group
scaling and root planing along with antibiotic interventionDRUG

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

Also known as: Systemic antibiotics
Group B-Interventional group

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • systemic diseases
  • under antibiotics or anti-inflammatory drugs within previous 3 months
  • pregnant and lactating women
  • allergic to antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27027501BACKGROUND

  • 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.

    PMID: 25142259BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Sandhya CH, BDS

    Meenakshi Ammal Dental College & Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A - scaling and root planing Group B - scaling and root planing along with antibiotic intervention of amoxicillin and metronidazole
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2017

First Posted

February 3, 2017

Study Start

March 1, 2016

Primary Completion

July 31, 2016

Study Completion

October 1, 2016

Last Updated

February 3, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share