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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scaling and root planing
scaling and root planing along with antibiotic intervention
Sponsored by
Meenakshi Ammal Dental College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chronic Periodontitis, TRAP-5b, Non-surgical periodontal therapy, Systemic antibiotics

Eligibility Criteria

30 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Group A -control group

    Group B-Interventional group

    Arm Description

    15 subjects underwent scaling and root planing

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Probing pocket depth
    Probing pocket depth was measured using Williams periodontal probe at baseline and at 3rd month
    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.

    Full Information

    First Posted
    January 28, 2017
    Last Updated
    February 1, 2017
    Sponsor
    Meenakshi Ammal Dental College and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03043066
    Brief Title
    Serum TRAP-5b Levels in Patients With Generalized Chronic Periodontitis
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    July 31, 2016 (Actual)
    Study Completion Date
    October 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Meenakshi Ammal Dental College and Hospital

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Chronic Periodontitis, TRAP-5b, Non-surgical periodontal therapy, Systemic antibiotics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group A - scaling and root planing Group B - scaling and root planing along with antibiotic intervention of amoxicillin and metronidazole
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A -control group
    Arm Type
    Placebo Comparator
    Arm Description
    15 subjects underwent scaling and root planing
    Arm Title
    Group B-Interventional group
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Scaling and root planing
    Other Intervention Name(s)
    Non-surgical periodontal therapy
    Intervention Description
    subjects underwent full mouth supragingival and subgingival scaling
    Intervention Type
    Drug
    Intervention Name(s)
    scaling and root planing along with antibiotic intervention
    Other Intervention Name(s)
    Systemic antibiotics
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Serum levels of TRAP-5b
    Description
    Concentration of serum levels of TRAP-5b was assessed at baseline and at 3rd month using ELISA method.
    Time Frame
    Baseline and 3 months
    Secondary Outcome Measure Information:
    Title
    Probing pocket depth
    Description
    Probing pocket depth was measured using Williams periodontal probe at baseline and at 3rd month
    Time Frame
    Baseline and 3 months
    Title
    Clinical attachment level
    Description
    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.
    Time Frame
    Baseline and 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandhya CH, BDS
    Organizational Affiliation
    Meenakshi Ammal Dental College & Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27027501
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25142259
    Citation
    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.
    Results Reference
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    Serum TRAP-5b Levels in Patients With Generalized Chronic Periodontitis

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