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Trial record 13 of 312 for:    "Periodontitis, Chronic"

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

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ClinicalTrials.gov Identifier: NCT03043066
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Dr.Jaideep Mahendra, 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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Scaling and root planing Drug: scaling and root planing along with antibiotic intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A - scaling and root planing Group B - scaling and root planing along with antibiotic intervention of amoxicillin and metronidazole
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : October 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: 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 Name: Systemic antibiotics




Primary Outcome Measures :
  1. Serum levels of TRAP-5b [ Time Frame: 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 :
  1. Probing pocket depth [ Time Frame: Baseline and 3 months ]
    Probing pocket depth was measured using Williams periodontal probe at baseline and at 3rd month

  2. Clinical attachment level [ Time Frame: 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.



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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043066


Sponsors and Collaborators
Meenakshi Ammal Dental College and Hospital
Investigators
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Principal Investigator: Sandhya CH, BDS Meenakshi Ammal Dental College & Hospital

Publications:
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Responsible Party: Dr.Jaideep Mahendra, Professor, Meenakshi Ammal Dental College and Hospital
ClinicalTrials.gov Identifier: NCT03043066     History of Changes
Other Study ID Numbers: MADC/IRB-IX/2016/193
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital:
Chronic Periodontitis
TRAP-5b
Non-surgical periodontal therapy
Systemic antibiotics

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Amoxicillin
Metronidazole
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents