Impact of an AI-Based Chatbot on Implant Patient Management: RCT

NCT07300657 | Completed

• 1 other identifier: Odonto-IA01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Dental implant therapy is a well-established and predictable procedure for replacing missing teeth, with high long-term survival rates. However, poor oral hygiene remains one of the main modifiable risk factors for peri-implant diseases such as mucositis and peri-implantitis. Objective: The aim of this randomized controlled clinical trial is to evaluate the effectiveness of an artificial intelligence (AI)-based chatbot, developed and validated by dental experts, in improving oral hygiene and clinical outcomes in patients with implant-supported restorations, compared to traditional educational methods such as printed leaflets and dental hygienist sessions. Methods: A total of 110 adult patients rehabilitated with dental implants were randomly assigned to either an AI chatbot intervention group or a control group receiving standard oral hygiene education. The chatbot provides continuous, personalized education and motivation through natural language interaction. Clinical and radiographic parameters, including plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), and marginal bone loss (MBL), were recorded at baseline and at follow-up visits. Expected outcomes: It is hypothesized that the use of an AI-based chatbot will significantly improve oral hygiene compliance and clinical outcomes compared to conventional methods. Significance: The study aims to demonstrate the potential of AI-assisted patient education in promoting long-term peri-implant health and preventing peri-implant diseases.

Conditions

Peri-Implant Mucositis; Peri-implantitis; Peri-Implant Health; Peri-implant Inflammation

Keywords

Dental Implants; Oral Hygiene; Artificial Intelligence; Chatbot; Patient Education; Peri-Implant Diseases; Peri-Implantitis; Mucositis; Randomized Controlled Trial; Preventive Dentistry

Outcome Measures

Primary Outcomes (1)

• Plaque Index (PI) Score at Implant Sites

  The PI is considered a direct indicator of the quality of oral hygiene at home and reflects the level of plaque control achieved by each participant. Measurements will be recorded using a standard four-grade scale (0-3) at six sites per implant by a blinded examiner.

  Baseline (prosthetic loading of implant) and 6 months after intervention start.

Secondary Outcomes (3)

• Presence of Bleeding on Probing (BOP) at Implant Sites

  Baseline (prosthetic loading of implant) and 6 months after intervention start.

• Presence of Suppuration on Probing (SUP) at Implant Sites

  Baseline (prosthetic loading of implant) and 6 months after intervention start.

• Marginal Bone Loss (MBL) in Millimeters at Implant Sites

  Baseline (prosthetic loading of implant) and 6 months after intervention start.

Study Arms (2)

Chatbot Group

EXPERIMENTAL

Participants receive oral hygiene education and motivational support through an AI-based chatbot developed and validated by dental professionals.

Behavioral: AI Chatbot

Control Group

ACTIVE COMPARATOR

Participants receive standard oral hygiene education through printed informational leaflets and scheduled sessions with a dental hygienist.

Behavioral: Standard Oral Hygiene Education

Interventions

AI Chatbot BEHAVIORAL

An artificial intelligence-based chatbot specifically designed and validated by dental experts to provide personalized oral hygiene education and motivational support.

Chatbot Group

Standard Oral Hygiene Education BEHAVIORAL

Participants in the Control Group receive traditional oral hygiene education, including printed informational leaflets and scheduled sessions with a dental hygienist.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy or with controlled systemic conditions;
• Good periodontal health on either an intact or reduced periodontium;
• Regular adherence to supportive periodontal therapy (SPT);
• Presence of at least one osseointegrated dental implant in the maxilla or mandible, following transmucosal healing for 2-4 months;
• Daily access to a smartphone.

You may not qualify if:

• Age \< 18 years;
• Untreated or active periodontal disease;
• Currently undergoing orthodontic therapy;
• Patients with cognitive deficits;
• Smoking habit (more than 10 cigarettes per day);
• History of heavy alcohol consumption;
• Use of immunosuppressive medication;
• Pregnancy or lactation.

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

Intradepartmental Program of Oral Surgery and Early Detection of Oral Cancer, G. Rodolico - San Marco Hospital, AOU Policlinico - San Marco

Catania, 95124, Italy

Location

MeSH Terms

Conditions

Peri-Implantitis; Mucositis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Participants are randomly assigned to either the AI-based chatbot intervention group or the standard oral hygiene education control group. Each participant receives only one intervention during the study. Randomization ensures balanced allocation and reduces selection bias.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 24, 2025
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD and supporting information will be available after publication of the primary study results and will remain accessible for a period of 5 years following publication.
• Access Criteria: pubmed

Locations

IT (1)