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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043066
• Other study ID #: MADC/IRB-IX/2016/193
• Status: Completed
• Phase: N/A
• First received: January 28, 2017
• Last updated: February 1, 2017
• Start date: March 1, 2016
• Est. completion date: October 1, 2016

Study information

• Verified date: January 2017
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2016
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• Scaling and root planing
subjects underwent full mouth supragingival and subgingival scaling

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

References & 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Probing pocket depth	Probing pocket depth was measured using Williams periodontal probe at baseline and at 3rd month	Baseline and 3 months
Secondary	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.	Baseline and 3 months