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

Analysis of the Treatment of Non-surgical Peri-implant Mucositis Treatment in Patients With Tissue-level (TL) and Bone-level (BL) Implants

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.

Study Overview

• Status: Completed
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98100
    • University of Messina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Male and female aged > 18 years
• TL and BL titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with PM (Berglundh, et al.,2018)
• Implants placed in both arches
• Patients with gingivitis or treated periodontitis (i.e., absence of residual PD > 5 mm)
• Presence of at least 2 mm of keratinized mucosa at implant sites.

Exclusion criteria:

• presence of medical conditions contraindicating treatment of peri-implant mucositis,

• regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment

  • Presence of systemic diseases
  • Pregnant and lactating females
  • Smokers > 10 cigarettes/day
  • Use of inflammatory drugs or antibiotics within 3 months prior to study recruitment
  • Implants with modified (i.e. micro-rough) necks
  • Interproximal open contacts between implant restoration and adjacent teeth
  • Peri-implantitis (Renvert, et al., 2018)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tissue level implant Group; 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)	Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy; Statistically significant different in terms of Bleeding on Probing will be recorded between groups.
Experimental: Bone level implant Group; 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).	Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy; Statistically significant different in terms of Bleeding on Probing will be recorded between groups.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full mouth plaque score (FMPS) changes	Chenges in Full mouth plaque score (FMPS) (parameter)	Baseline (T0), 3-months (T1) and at 6-months (T2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket probing depth (PD) mm changes	changes in Pocket probing depth (PD)	Baseline (T0), 3-months (T1) and at 6-months (T2)
Presence of plaque at implant sites according to plaque index (PlI)	Changes in presence of plaque at implant sites according to plaque index (PlI)	Baseline (T0), 3-months (T1) and at 6-months (T2)

Collaborators and Investigators

• Sponsor: University of Messina
• Investigators: Principal Investigator: Gaetano Isola, Università degli Studi di Mesina

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: 2021-18/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing study results
• IPD Sharing Time Frame: 6-months
• IPD Sharing Access Criteria: Pubmed website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No