Detecting perfusion parameters of gingival inflammation by using Laser-Doppler-flowmetry and tissue spectrophotometry- a prospective controlled clinical study

• Conditions: K05.1; Chronic gingivitis

• Registration Number: DRKS00024048
• Lead Sponsor: niklinik RWTH Aachen,Klinik für Mund-Kiefer- und Gesichtschirurgie

Brief Summary

s a non-invasive method, LDF-TS can help determine gingival hyperemia. Flow values above 40 AU indicate a higher risk of hyperemia, which can be associated with inflammation. The LDF-TS method can be used for the objective evaluation of perfusion parameters during routine examinations and can signal the progression of hyperperfusion before any change in clinical parameters is observed.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-15
• Study Completion: 2022-03-01
• Results First Posted: 2023-10-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

To be included in our study, patients have to be aged at least 18 years and have to be in good general health (ASA I-II based on the American Society of Anesthesiologists). Further inclusion criteria are: No missing teeth except for the second and third molars, no dental implants in the region of interest and consent to a gingival and periodontal examination. Smokers without signs of gingivitis are excluded as smoking can lead to decreased perfusion of the gum and could therefore mask an underlying inflammation.
Patients can only be included if they consent to participate by signing a written informed consent form.

Exclusion Criteria

Patients with signs of acute infection or intraoral swelling cannot participate in this study. Further exclusion criteria are:
Patients who smoked less than 2 hours before the examination and patients with missing teeth or dental implants.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of this prospective controlled clinical study is to determine values for various perfusion parameters such as gingival hemoglobin saturation, blood flow and blood velocity and to compare these with the clinical examination results of patients with and without gingivitis. <br>After the examination of at least 50 patients with and at least 50 patients without gingivitis has been completed, the values of the clinical examinations (probing depths, bleeding on probing, plaque and gingivitis index, biotype) are compared with the results of the perfusion measurements (oxygen saturation, blood flow and velocity, hemoglobin values) and correlations are determined.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the perfusion-related and clinical values.