Comparing Different Timings for Periodontal Re-evaluation After Non-surgical Periodontal Therapy (NSPT)

Periodontitis Clinical Trial

Official title: Comparing Different Timings for Periodontal Re-evaluation After Non-surgical Periodontal Therapy (NSPT)

Status Recruiting

Clinical Trial Summary

This is a prospective cohort study that aims to describe the difference in terms of percentage of closed pockets (PPD <5 mm and no BOP) when performing the periodontal re-evaluation at 3-4, 6-8 and 12 months. Fifty-two, ≥18-year old, otherwise healthy, periodontitis patients will be recruited at Centro di Odontoiatria, Università di Parma.

Clinical Trial Description

This is a prospective cohort study describing the difference in terms of percentage of closed pockets (PPD <5 mm and no BOP) when performing the periodontal re-evaluation at 3-4, 6-8 or 12 months. The trial will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement. The study consists of 7 visits over a period of 15 months. Visit 1 - Baseline - - Informed consent, medical/dental history and demographics - Record concomitant medications and smoking history - Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth. - Standardized peri-apical x-rays for the sites with PPD≥5mm, as per standard of practice (if not already available within the previous 6 months) - Intra-oral 3D scan - Oral hygiene instructions and demonstration of self-performed oral hygiene measures - PROMs questionnaires - Saliva collection and GCF collection from the deepest pockets (maximum of 5 sites) Visit 2 and 3 - NSPT - (and extra visit 3.1 and 3.2 if needed) (within 60 days from baseline) - Update medical/dental history and record adverse events and/or concomitant medications - NSPT, consisting in the careful removal of hard and soft deposits with ultrasonic instruments at infected sites performed by an experienced clinician following the principles of minimally invasive non-surgical therapy (MINST). A quadrant approach will be adopted and it will be left to the discretion of the clinician to choose whether to instrument 1 or 2 quadrants at a time and the length of session visits. Hence, 2 to 4 sessions of NSPT with an interval of 1 week between each other will be performed. During NSPT, teeth considered hopeless will be extracted as per standard of practice. - Reinforcement of oral hygiene instructions - PROMs questionnaires Extra visits outside the study protocol may be arranged in case the patients need extractions or other dental treatments besides NSPT. Visit 4 (4-6 weeks from the end of NSPT) - Update medical/dental history and record adverse events and/or concomitant medications - Visual inspection of signs of inflammation and plaque - Supragingival polish and reinforcement of oral hygiene instructions - PROMs questionnaires - Intra-oral 3D scan Visit 5 (3-4 months from the end of NSPT) - Update medical/dental history and record adverse events and/or concomitant medications - Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth. - PROMs questionnaires - Intra-oral 3D scan - Saliva collection and GCF collection from the same sites identified at baseline - Supragingival polish and reinforcement of oral hygiene instructions Visit 6 (6-8 months from the end of NSPT) - Update medical/dental history and record adverse events and/or concomitant medications - Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth. - PROMs questionnaires - Intra-oral 3D scan - Saliva collection and GCF collection from the same sites identified at baseline - Supragingival polish and reinforcement of oral hygiene instructions Visit 7 (12 months ± 14 days from the end of NSPT) - Update medical/dental history and record adverse events and/or concomitant medications - Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, PI, mobility and furcation involvement. PPD, REC, PI and BOP will be recorded at 6 sites per tooth. - PROMs questionnaires - Intra-oral 3D scan - Standardized peri-apical x-rays - Saliva collection and GCF collection from the same sites identified at baseline - Supragingival polish and reinforcement of oral hygiene instructions Photos and videos may be taken/recorded in any of the study visits for documentation purposes. The subject will not be identifiable from those photos/videos. ;

Related Conditions & MeSH terms

• Periodontal Pocket
• Periodontitis

• NCT number: NCT05088746
• Study type: Observational
• Source: University of Parma
• Contact: Elena Calciolari, DDS, MS, PhD
• Phone: 0521 033640
• Email: elena.calciolari@unipr.it
• Status: Recruiting
• Start date: June 1, 2021
• Completion date: September 2023