Application of Information-Motivation-Behavioral Model-based Continuity of Care on the Peri-implantitis Recovery in Diabetic Implant Overdenture Patients

Application of Information-Motivation-Behavioral Model-based Continuity of Care on the Peri-implantitis Recovery in Diabetic Implant Overdenture Patients: A Randomised Controlled Trial

The investigators recruited 32 diabetic IOD patients with a total of 110 problematic implants who had completed the treatment for peri-implantitis between January 2021 and March 2023 as research subjects. The patients were randomly assigned to the control group or the experimental group using the random number table. The control group received routine postoperative medical advice, whereas the experimental group was given an IMB model-based continuity of care.

Study Overview

• Status: Completed
• Conditions: Diabetes; Bone Resorption
• Intervention / Treatment: Behavioral: IMB model-based continuity of care

Detailed Description

Continuity of care involves a series of actions designed to ensure that patients undergoing a transfer from different health care settings (e.g., from hospital to home) or within the same setting (e.g., different units in the hospital) receive different levels of collaborative and continuous care, including discharge planning, referrals, and continuous follow-up and guidance after the patient returns home . It encompasses the roles of both provider and receiver. Patients who actively participate will receive more substantial treatment. Additionally, a retrospective cohort study has shown that continuity of care is associated with lower risk of cardiovascular disease risk among individuals with type 2 diabetes. Another prospective cohort has shown that the application of continuity of care in the dental field enhances oral anticancer therapy adherence.

The information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements-information, motivation, and behavioral skills-and is aimed at transferring patients' behavior into a positive direction, including self-behavior management ability, medication compliance and so on. For diabetic patients with poor adherence, the IMB model of care can be considered.

This model may be particularly useful in diabetic IOD patients since they are more prone to peri-implantitis than patients with other types of implant restorations or non-diabetic patients. However, the efficacy of the combination of the IMB model and continuity of care in improving healing, bone resorption, disease management and control, and quality of life in the specific population group of diabetic IOD patients remains unclear. To this end, the current study was aimed at investigating whether this model of care can help achieve better clinical outcomes and improve patient satisfaction with the services provided, thereby obtaining data to serve as a reference and scientific basis for the improvement of intervention plans.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The Stomatologic Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The inclusion criteria in this study were as follows:

1. IOD patients who had type 2 diabetes with peri-implantitis in at least one implant,
2. patients with clear consciousness and good communicative competence,
3. patients who could take good care of themselves and were proficient in using mobile communication and internet devices
4. patients who agreed to participate in our study.

Exclusion Criteria:

Patients with any of the following were excluded from our study:

1. type 1 diabetes and other particular types of diabetes,
2. severe cognitive dysfunction or psychiatric disorders, and
3. inability to use mobile electronic devices.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMB model-based continuity of care; Intervention through the IMB model-based continuity of care was focused on three aspects: Information intervention: (a) instructing patients to follow the official account of the dental implant department and introducing the instructions to use the application, (b) regularly updating the educational content and disseminating detailed knowledge about the prevention and treatment of oral diseases, especially for peri-implantitis.; Motivation intervention: (a) providing an online platform for patients to interact with nurses and doctors, where they can obtain professional answers. (b) assessing the risk factors related to peri-implantitis and diabetes and developing appropriate interventions; Behavioral skills intervention: (a) providing feedback on the correct use of tools and implants and cleaning of the overdentures by observing the cleaning videos that the patients were required to upload.	Behavioral: IMB model-based continuity of care; The information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements-information, motivation, and behavioral skills-and is aimed at transferring patients' behavior into a positive direction, including self-behavior management ability, medication compliance and so on. For diabetic patients with poor adherence, the IMB model of care can be considered.
No Intervention: routine health education; For the control group, standard care was provided in the form of routine health education regarding various topics, such as proper brushing techniques, use of an oral irrigator, and other auxiliary tools. The patients were followed-up via telephonic interviews to monitor their condition, including usage of the implant and lifestyle changes; the interviews were conducted at 2 weeks, 1 month, 3 months, and 6 months after treatment. Data were collected about oral health, blood glucose control, lifestyle habits, and comorbidities by using the compliance questionnaire. Appropriated health education was provided if there were any concerns such as gingival swelling, plaque accumulation, and elevated blood glucose levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant bone resorption	Each patient received at least 3 panoramic radiographs on the first day patients came to our hospital for treatment of peri-implantitis (T0), 6 months after treatment (T1), and 12 months after treatment (T2), respectively. The distances from the most coronal implant-bone junction site to the implant platform in both the mesial and distal sites of the implants were measured and recorded as measured mesial bone level (mMBL) and measured distal bone level (mDBL) respectively. The lengths of the implants were measured in order to calibrate the measurements by using the actual known length of the implant, for example, the actual MBL(aMBL) = mMBL × (actual implant length) / (measured implant length). We obtained the average value of aMBL and aDBL, regarded T0 as the baseline, and subtracted T0 from T1 or T2 to acquire the bone loss in 6 or 12 months after treatment.	1-2years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	An in-house questionnaire was developed to assess the patients' satisfaction regarding nurses service attitude, timeliness of responses, effectiveness in controlling peri-implant inflammation, and feelings about their own condition. The scores ranged from 1 to 10, with higher scores indicating greater satisfaction.	1-2years

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): September 20, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Bone Resorption; Peri-Implantitis
• Other Study ID Numbers: DHZhejiangU-2023(005)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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