Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05162963 |
| Other study ID # |
APHP210087 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
May 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Claudine Wulfman, Professor |
| Phone |
33 6 58 37 21 95 |
| Email |
claudine.wulfman[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Edentulism is defined as the loss of all natural teeth and is an important public health
issue globally for its high prevalence (exceeding 10% in adults aged ≥ 50 years) and
associated disability Epidemiological studies show a decrease in the prevalence of total
edentulism but an increase in the number of edentulous people in the world in general and in
Western society in particular, linked to the increase in life expectancy. In Europe, the
edentulism rate varies greatly from one country to another. According to the WHO, in the 65+
age group, the rate of total edentulism in 2000 was 60-70% in some European countries and
still 15% in France.
Prosthetic rehabilitation is a factor of social inequalities in health insofar as this care
is poorly covered or not covered by social organizations. The different treatment solutions
must be examined in terms of the gain they represent in terms of quality of life compared to
their cost.
The improvement of retention of a removable prosthesis with implants was demonstrated. The
comparison between fixed and removable implant-retained 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. This treatment
option is not well known. There are no randomized controlled studies directly comparing these
two therapies in terms of quality of life.
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, i.e. twice during the study.
The GOHAI is a specific oral quality of life scale, comprising 12 items scored from 1 to 5
divided into 3 subparts corresponding to the functions of speaking, eating, and swallowing,
psychosocial aspects, and pain/discomfort. A score of 60 corresponds to an optimal quality of
life.
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.
Experimental design All 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. All patients will receive specific training in oral
and peri-implant hygiene. 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. No residual effect are expected, but the
assessment of the baseline quality of life require daily use of the conventional prosthesis
(without implant). Then, during a second period of 6 months, the patients will be using the
second prosthesis. At the end of the study, the patient will choose the prosthesis he prefers
and justifies his choice in a specific questionnaire.
A measurement of quality of life (GOHAI questionnaire) will be carried out before treatment
and after use of each type of prosthesis. At the 6-month appointment of each prosthesis,
evaluations will be performed including a plaque index measurement and a masticatory
efficiency test. The adjustments and repairs required during the time the prosthesis will be
worn, as well as the time required to perform them, will be recorded. A follow-up of the
complications that occurred on each type of prosthesis will be set up during the two
prosthetic phases.
The analysis will be carried out in intention-to-treat and per-protocol analysis. The
treatment effect will be estimated by the difference in the evolution of the GOHAI score
between the period with a removable prosthesis and the period without a removable prosthesis
and its 95% confidence interval. A sequence and carry over effect will be sought.
