Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants

Not Applicable

Completed

• Conditions: Peri-implant Mucositis
• Interventions: Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy

• Registration Number: NCT04751565
• Lead Sponsor: University of Messina

Brief Summary

This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.

Detailed Description

Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical mechanical debridement.

Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-12
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tissue level implant Group	Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy	Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with tissue level implant Primary outcome The primary outcome will be based on probing depth (PD)
Bone level implant Group	Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy	Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with bone level implant Primary outcome The primary outcome will be the change in Bleeding on Probing (BOP) (Lang, Joss, Orsanic, Gusberti, Siegrist, 1986).

Primary Outcome Measures

Name	Time	Method
Bleeding on Probing (BOP) changes	Baseline (T0), 3-months (T1) and at 6-months (T2)	Changes over time in BOP changes (percentage)

Secondary Outcome Measures

Name	Time	Method
Full mouth plaque score (FMPS) changes	Baseline (T0), 3-months (T1) and at 6-months (T2)	Chenges in Full mouth plaque score (FMPS) (parameter)

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy