Impact of Removable Versus Fixed Implant-supported Prostheses in Oral Health Quality of Life for Edentulous Patients

NCT05162963 | Unknown

• 1 other identifier: APHP210087
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison between fixed and removable implant-retained complete prostheses previously showed that while patients appreciate the ergonomic cleaning of removable prostheses, they prefer the comfort and masticatory efficiency of fixed prostheses. New treatment strategies are emerging; the use of telescopic attachments now offers a prosthetic alternative for the treatment of edentulous teeth at a lower financial cost than fixed prostheses. To answer this question, the study is constructed as a cross-over. 30 patients will use a removable telescopic prosthesis and then a fixed prosthesis, or vice versa, for a period of 6 months according to randomization. They will answer a quality of life questionnaire after each period and finally choose their favorite prosthesis. The null hypothesis is that removable telescopic implant prostheses will result in a quality of life comparable to that obtained with fixed implant-supported prostheses. The primary objective of this study is to demonstrate the non-inferiority of removable versus fixed prostheses on quality of life after 6 months of use of each implant-supported prosthesis in edentulous maxillary or mandibular patients. The measurement of the evolution of the quality of life is analyzed using the GOHAI questionnaire after 6 months of use of each prosthesis. The secondary objectives are to:

• Determine the decisional parameters in the final choice of the prosthesis by the patient at the end of the study, with the Mc Gill Denture Satisfaction Instrument,
• Compare the masticatory efficiency between the two dentures (duration, number of cycles and frequency of chewing of the carrot test food, with each denture after 6 months of use),
• Compare the oral hygiene between the two prostheses (peri-implant plaque index, after 6 months for each prosthesis),
• Compare the adjustments and repair required after the placement of each prosthesis and the chairside treatment time to achieve them,
• Compare the complications and their frequency of occurrence with each type of prosthesis during the 6-month wearing period.

Conditions

Complete Edentulism

Keywords

Overdenture; Complete edentulism; Quality of life; Dental implant

Outcome Measures

Primary Outcomes (1)

• Measurement of the evolution of the quality of life using the GOHAI questionnaire

  Measurement of the evolution of the quality of life is analyzed using the GOHAI questionnaire

  6 months

Secondary Outcomes (7)

• Scores of the Mc Gill Denture Satisfaction Instrument

  21 months

• Measurement of the duration of chewing of the carrot test food

  6 months

• Measurement of the number of cycles of chewing of the carrot test food

  6 months

• Measurement of the frequency of chewing of the carrot test food

  6 months

• Peri-implant plaque index

  6 months

Study Arms (2)

Patients treated with fixed implant denture

ACTIVE COMPARATOR

Patients quality of life will be compared when using a removable implant denture and a fixed implant denture, in a cross-over design. Fixed denture is considered the standard protocol.

Other: fixed implant denture; Other: removable implant denture

Patients treated with removable implant denture

EXPERIMENTAL

Patients quality of life will be compared when using a removable implant denture and a fixed implant denture, in a cross-over design. Removable denture is considered the experimental protocol.

Other: fixed implant denture; Other: removable implant denture

Interventions

fixed implant denture OTHER

Patients will receive four or six dental implants, four in the mandible or six in the maxilla, depending on the arch to be treated. After an osseointegration phase of 4 to 6 months, two implant prostheses will be made for each patient, one removable, the other fixed. According to the randomization, during an initial period of 6 months, half of the patients will be using the removable prosthesis, the other half the fixed prosthesis. A 15-day washout will be performed. Then, during a second period of 6 months, the patients will be using the second prosthesis.

Patients treated with fixed implant denture; Patients treated with removable implant denture

removable implant denture OTHER

removable implant denture

Patients treated with fixed implant denture; Patients treated with removable implant denture

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years of age;
• Mandibular AND/OR maxillary edentulous patients, treated with satisfying conventional denture for a minimum of 3 months;
• Bone volume compatible with the placement of implants of at least 9 mm in length;
• Sufficient inter-arch space;
• Free and informed consent;
• Affiliated to the social security fund.

You may not qualify if:

• Systemic pathologies contraindicating the placement of implants (unbalanced diabetes, biphosphonates);
• Smoking patient \> 10 cigarettes per day;
• Class IV bone according to the Leckholm and Zarb classification.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Central Study Contacts

Claudine Wulfman, Professor

CONTACT

33 6 58 37 21 95; claudine.wulfman@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 20, 2021
• Study Start: February 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share