Clinical trial NCT03043066: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: Chronic Periodontitis
TRAP-5b
Non-surgical periodontal therapy
Systemic antibiotics
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A - scaling and root planing Group B - scaling and root planing along with antibiotic intervention of amoxicillin and metronidazole
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serum levels of TRAP-5b
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Probing pocket depth
timeFrame: Baseline and 3 months
measure: Clinical attachment level
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Meenakshi Ammal Dental College & Hospital
name: Sandhya CH, BDS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.