Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients With Obesity

Obesity Clinical Trial

Official title:

Effects of Antimicrobial Photodynamic Therapy in Non-surgical Periodontal Treatment of Patients With Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073704
• Other study ID #: Obesity and Periodontitis
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: December 23, 2024

Study information

• Verified date: February 2024
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (aPDT) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. The main question it aims to answer are: Does adjuvant aPDT improves periodontal health? Are there differences in the proteomic profile of gingival fluid after both treatments? Participants will receive scaling and root planing complemented or not by aPDT. Results will be collected after 1, 3, and 6 months. Researchers will compare adjuvant aPDT treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 23, 2024
• Est. primary completion date: October 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Obesity (grade II and III classified according to Body Mass Index)

• Periodontitis stage II to IV

• Presence of at least 20 teeth excluding 3rd molars.

Exclusion Criteria:

• Smokers

• Alcohol or drugs consumption

• Kidney disorders

• Pregnancy or lactation

• Use of antibiotics at the last 30 days

• Use of drugs that alter periodontal structures as phenytoin or ciclosporin

• Periodontal treatment at the last 6 months

Related Conditions & MeSH terms

• Obesity
• Periodontitis

Intervention

Procedure:
• antimicrobial photodynamic therapy (aPDT)
Scaling and root planing followed by antimicrobial photodynamic therapy
• Control
Treatment of scaling and root planing

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry	Bauru	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

da Silva-Junior PGB, Abreu LG, Costa FO, Cota LOM, Esteves-Lima RP. The effect of antimicrobial photodynamic therapy adjunct to non-surgical periodontal therapy on the treatment of periodontitis in individuals with type 2 diabetes mellitus: A systematic review and meta-analysis. Photodiagnosis Photodyn Ther. 2023 Jun;42:103573. doi: 10.1016/j.pdpdt.2023.103573. Epub 2023 Apr 14. — View Citation

Vohra F, Akram Z, Bukhari IA, Sheikh SA, Javed F. Short-term effects of adjunctive antimicrobial photodynamic therapy in obese patients with chronic periodontitis: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2018 Mar;21:10-15. doi: 10.1016/j.pdpdt.2017.10.022. Epub 2017 Oct 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth	Changes in probing depth measured from the gingival margin to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters.	Baseline, 1, 3 and 6 months
Primary	Clinical attachment level	Changes in clinical attachment level measured from the cemento-enamel junction to the bottom of periodontal sulcus or periodontal pocket by a periodontal probe in millimeters.	Baseline, 1, 3 and 6 months
Secondary	Changes on bleeding on probing	Changes in percentage of sites with bleeding after probing. Six sites per tooth are examined and presence/absence of bleeding is recorded.	Baseline, 1,3,and 6 months
Secondary	Differences in proteomics	Changes in inflammatory proteins after treatment by proteomics assay. Presence or absence of proteins in gingival fluid are compared before and after treatment.	baseline, 3 and 6 months