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