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

NCT06901388 | Completed

• 1 other identifier: BIPP001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-implant Mucositis; Peri-Implantitis

Keywords

Oral Health Impact Profile 14; Brief-Illness Perception Questionnaire; Non-surgical peri-implant therapy

Outcome Measures

Primary Outcomes (1)

• Change in illness perception (Brief-IPQ total score)

  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

Study Arms (1)

Single group

EXPERIMENTAL

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

Interventions

Non-surgical peri-implant therapy PROCEDURE

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.

Also known as: Mechanical debridement + Oral hygiene instruction

Single group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: March 28, 2025
• Study Start: March 31, 2025
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

IT (1)