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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06103799
• Other study ID #: DHZhejiangU-2023(005)
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: The Dental Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 30, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Resorption
• Diabetes
• Peri-Implantitis

Intervention

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.

Locations

Country	Name	City	State
China	The Stomatologic Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Dental Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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