Peri-implant Disease Perception Before and After Non-Surgical Peri-implant Therapy

July 29, 2025 updated by: Nicola Discepoli, University of Siena

Peri-implant Disease Perception Before and After Non-Surgical Peri-implant Therapy: A Pre-post Quasi-Experimental Study

The present pre-post quasi-experimental study assessed changes in peri-implant disease perception and oral health-related quality of life following non-surgical peri-implant therapy. Using validated psychometric tools, including the Brief Illness Perception Questionnaire (Brief-IPQ) and the Oral Health Impact Profile-14 (OHIP-14), the study evaluates patients at baseline and three months after therapy. The study builds upon prior cross-sectional findings highlighting the low perception of peri-implant diseases and aims to determine whether non-surgical treatment improves patients' psychological awareness and perceived impact of their condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena, Italy, 53100
        • AOUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 to 80 years
  • Diagnosis of peri-implant disease requiring non-surgical therapy
  • Presence of at least one dental implant loaded for a minimum of one year
  • History of periodontitis
  • Good general health
  • Ability to provide written informed consen

Exclusion Criteria:

  • Pregnant or lactating individuals
  • Inability to perform basic oral hygiene procedures
  • Inability to understand or complete study questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single group
All participants will receive non-surgical peri-implant therapy consisting of mechanical debridement and oral hygiene instruction. Psychometric assessments (Brief-IPQ and OHIP-14) will be administered at baseline and 3 months after treatment to evaluate changes in illness perception and oral health-related quality of life.
Procedure: Non-surgical peri-implant therapy
Standardized non-surgical therapy consisting of mechanical debridement of peri-implant sites using ultrasonic instruments, combined with personalized oral hygiene instruction. The intervention is delivered in a single session. No adjunctive antimicrobials are used. Follow-up is scheduled 3 months after therapy for clinical and psychometric re-evaluation.
Other Names:
  • Mechanical debridement + Oral hygiene instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in illness perception (Brief-IPQ total score)
Time Frame: Baseline and 3 months from baseline
Illness perception will be assessed using the Brief Illness Perception Questionnaire (Brief-IPQ). The primary outcome is the change in the total score from baseline to 3 months after baseline, following non-surgical peri-implant therapy.
Baseline and 3 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Actual)

July 29, 2025

Study Completion (Actual)

July 29, 2025

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

March 22, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIPP001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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