Timing of Re-evaluation After Steps I-II of Periodontal Therapy

NCT05892315 | Unknown

• 1 other identifier: UTurin3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Literature on non surgical periodontal therapy (NSPT) shows lack of clarity in reporting information on re-evaluation timing and clinical response. If the re-evaluation was done shortly after NSPT, this is also likely to have an influence on the surgical treatment plan. The aim of this randomized clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, probing pocket depth reduction, comprehensive treatment plan, and costs for the patient.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in treatment success % (0 - 100 % with higher percentage indicating better status)

  Percentage of pockets ≥ 4 mm with bleeding that converted to ≤ 3 mm or ≤4 mm without bleeding at the completion of non-surgical periodontal therapy

  Baseline, 1 month, 3 months and 6 months after the completion of the therapy.

Secondary Outcomes (3)

• Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status)

  Baseline, 1 month, 3 months and 6 months after the completion of the therapy.

• Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes).

  Baseline, 1 month, 3 months and 6 months after the completion of the therapy.

• Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes).

  Baseline, 1 month, 3 months and 6 months after the completion of the therapy.

Study Arms (2)

Repeated subgingival instrumentation

EXPERIMENTAL

Conventional staged debridement (CSD) according to the severity of periodontitis in 2 to 4 appointments at day 0, 7, 14 and 21. Re-instrumentation at 6 weeks and 3 months after completion of step I-II.

Procedure: Repeated subgingival instrumentation

Supragingival instrumentation

ACTIVE COMPARATOR

Conventional staged debridement (CSD) according to the severity of periodontitis in 2 to 4 appointments at day 0, 7, 14 and 21. Only supragingival instrumentation at 6 weeks and 3 months after completion of step I-II.

Procedure: Supragingival scaling

Interventions

Repeated subgingival instrumentation PROCEDURE

Supragingival scaling will be performed at sites with plaque and subgingival scaling will be performed by the use of manual and ultrasonic instruments at pockets ≥ 4 mm with bleeding. Oral hygiene instructions will be reinforced. Patients will be instructed to use interdental brushes with appropriate size interdental brushes or dental floss when interdental embrasures will not allow for interdental brushing.

Repeated subgingival instrumentation

Supragingival scaling PROCEDURE

Supragingival scaling will be performed at sites with plaque. Oral hygiene instructions will be reinforced. Patients will be instructed to use interdental brushes with appropriate size interdental brushes or dental floss when interdental embrasures will not allow for interdental brushing.

Supragingival instrumentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Periodontitis stage III-IV
• Full-mouth plaque score (FMPS) \< 25% at the 1-month re-evaluation
• Full-mouth bleeding score (FMBS) \< 25% at the 1-month re-evaluation
• Signed informed consent

You may not qualify if:

• Age \< 18 yo
• Pregnancy or lactation
• Heavy smokers (\>10 die)
• Conditions or diseases influencing periodontal healing
• Patients that cannot complete the 6 months follow-up

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

CIR Dental School

Turin, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Dental Scaling

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Preventive Dentistry

Central Study Contacts

Mario Aimetti, Professor

CONTACT

00390116331541; mario.aimetti@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 7, 2023
• Study Start: May 11, 2023
• Primary Completion: June 11, 2024
• Study Completion: December 11, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

IT (1)