NCT05088746

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 52 (estimated)
• Sponsor: University of Parma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Periodontitis
• Periodontal Pocket

Interventions

Type	Name	Description
PROCEDURE	Non-surgical periodontal therapy	NSPT will be performed following the principles of minimally invasive non-surgical therapy (MINST) described by Nibali et al. (Nibali et al., 2015, Nibali et al., 2019)

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-10-22
• Last updated: 2025-04-17

Locations

1 site across 1 country: Italy