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OpenTrials
Completed

NCT Number: NCT03043066

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

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scaling and Root Planing

Procedure

subjects underwent full mouth supragingival and subgingival scaling

Other names: Non-surgical periodontal therapy

scaling and root planing along with antibiotic intervention

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

Other names: Systemic antibiotics

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Meenakshi Ammal Dental College and Hospital

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2017
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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