CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Periodontal surgery +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT04663165
NCT04663165N/ACompleted

Biomarkers in Gingival Exudate and Blood Serum Before and After Surgical Treatment of Periodontitis

Anders Holmlund·interventional·Posted Dec 10, 2020·Updated Dec 10, 2020

In Brief

A clinical study evaluating Periodontal surgery and Regenerative periodontal surgery for Periodontitis. Completed, enrolled 21 participants across 2 sites.

Detailed Summary

In this clinical study, we have collected GCF at diseased teeth and at the same time drawn blood, both before and at 3, 6 and 12 months after periodontal surgical treatment. This give us the opportunity to investigate if periodontal treatment could reduce inflammatory biomarkers in the systemic circulation and if there is a co-variation between biomarkers in GCF and blood. In part I of this study, we focus on biomarkers from blood serum in patients with periodontitis, before surgical therapy and under a healing period 12 months. In part II, biomarkers in the locally collected GCF will be analyzed together with clinically reported measurements and compared with biomarkers in blood serum. Hypothesis are * Periodontal treatment followed by clinical healing and periodontal health will be associated a change/ reduction in biomarkers in GCF. * The systemic levels of inflammatory biomarkers may show a delayed response to clinical healing. Periodontal surgical therapy may reduce circulating inflammatory biomarkers that could affect the low-grade chronic inflammation. * There is a co-variation between inflammatory biomarkers in GCF and the systemic circulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeriodontitis
CountriesSweden
CollaboratorsUmeå University

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2020
Enrollment StartFeb 4, 2010
Primary CompletionSep 23, 2013
Study CompletionJan 12, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 5.6 years ago

Interventions

Periodontal surgeryprocedure

Flap surgery at teeth with periodontal pocket depth 5 mm or more with additional bleeding or pus on probing. Elimination of dental calculus and granulation tissue as well as scaling of the root surface with scalers and ultrasonic device. Flap closure with non-resorbable sutures.

Regenerative periodontal surgeryprocedure

Flap surgery at teeth with periodontal pocket depth 5 mm or more with additional bleeding or pus on probing combined with vertical bone defect of 4mm or more. After elimination of dental calculus and granulation tissue as well as scaling of the root surface with scalers and ultrasonic device, adjunctive treatment with EDTA gel applied to root surface for two minutes, followed by rinsing with saline solution. Finally, application of enamel matrix derivative on a blood free root surface, followed by flap closure with non-resorbable sutures.