NCT04236648

Minimally-invasive Non-surgical Treatment in Teeth With Unfavourable Prognosis

Clinical and Radiographic Changes Following Minimally-invasive Non-surgical Therapy in Teeth With Unfavourable Prognosis: A Pilot Prospective Cohort Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot prospective cohort study to assess the efficacy of minimally-invasive non-surgical periodontal therapy (MINST) for the treatment of teeth with unfavourable periodontal prognosis. 20 patients who have teeth with unfavourable periodontal prognosis (due to bone loss to the apex or furcation involvement grade II C) will receive minimally-invasive non-surgical treatment (MINST) and will be reassessed up to 12 months after treatment.

Detailed description

Twenty patients with advanced periodontitis who have teeth with unfavourable periodontal prognosis (due to bone loss to the apex or furcation involvement grade II C) will be entered in this study, conducted at Guy's Hospital in London, UK. The study has a prospective cohort design, so following baseline assessment, all patients will receive minimally-invasive non-surgical treatment (MINST). A total of 10 visits are planned over a 12-13 months period including initial treatment (MINST) and follow-up appointments. The primary outcomes are radiographic defect depth (for teeth with bone loss to the apex, n=10) and furcation involvement (for teeth with furcation involvement degree II C, n=10). Paired t-test will be used to detect significant changes between baseline and 12 months for the primary outcomes using the patient as unit of analysis. Additional outcomes will be probing pocket depths (PPD), clinical attachment level (CAL), levels of inflammatory markers and growth factors in gingival crevicular fluid (GCF) and saliva and bacterial detection in periodontal pockets

Conditions

• Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Minimally-invasive non-surgical therapy (MINST)	subgingival root debridement with a minimally-invasive approach using piezoelectric/ultrasonic instruments

Timeline

• Start date: 2020-02-01
• Primary completion: 2021-10-31
• Completion: 2023-10-31
• First posted: 2020-01-22
• Last updated: 2020-01-22