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

Periodontitis Clinical Trial

Official title:

Timing of Re-evaluation After Steps I-II of Periodontal Therapy: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05892315
• Other study ID #: UTurin3
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2023
• Est. completion date: December 11, 2024

Study information

• Verified date: January 2024
• Source: University of Turin, Italy
• Contact: Mario Aimetti, Professor
• Phone: 00390116331541
• Email: mario.aimetti[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 11, 2024
• Est. primary completion date: June 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Repeated subgingival instrumentation
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.
• Supragingival scaling
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.

Locations

Country	Name	City	State
Italy	CIR Dental School	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status)	Percentage of full mouth plaque score considering 6 sited for each tooth.	Baseline, 1 month, 3 months and 6 months after the completion of the therapy.
Secondary	Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes).	The distance between the cementoenamel junction (CEJ) and the base of the pocket.	Baseline, 1 month, 3 months and 6 months after the completion of the therapy.
Secondary	Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes).	The sum of Probing pocket depth (PD, mm) and Recession (Rec, mm).	Baseline, 1 month, 3 months and 6 months after the completion of the therapy.