The primary goal is to assess the survival rate of dental implants placed in cleft patients compared to non-cleft patients. Secondary objectives will be: evaluation of the parameters on the survival of dental implants (smoking, oral hygiene, length…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Kaakchirurgische ingrepen, implantologie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
From the patients who received a dental implant data will be retrospectively
collected about when they received the implant, possible parameters which could
impact the survival rate (smoking, oral hygiene, length of dental implant,
diameter of dental implant, interval between secondary cleft repair and implant
placement, interval between tertiary cleft repair and implant placement, type
of tertiary cleft repair (horizontal, vertical or both)), and the date of
failure if there was an indication of removal of dental implant or indication
that the dental implant lost functionality.
Secondary outcome
From the patients who received a dental implant data will be prospectively
collected. The patients will be visiting once. During this visit a calibrated
periodontal probe will be used to measure BoP and PD, a radiograph of the
implant will be taken using a standardized method and PROM will be measured
using the Dutch translation of the Oral Health Impact Profile (OHIP- NL49) for
the situation before and after implantation of an dental implant.
Background summary
Hypodontia is a common phenomenon in patients with orofacial clefts. The upper
lateral incisor is the most susceptible to be missing in case of hypodontia.
Nowadays, dental implants in patients with an alveolar cleft are seen as an
excellent treatment option, because it is a safe procedure with a good
prognosis and low morbidity. There is a lack of papers reporting the difference
of survival rates of dental implants between cleft and non-cleft patients with
a longer follow-up than 5 years. Also, not much is known about the satisfaction
of patients who received a dental implant.
Study objective
The primary goal is to assess the survival rate of dental implants placed in
cleft patients compared to non-cleft patients. Secondary objectives will be:
evaluation of the parameters on the survival of dental implants (smoking, oral
hygiene, length of dental implant, diameter of dental implant, interval between
secondary cleft repair and implant placement, interval between tertiary cleft
repair and implant placement, type of tertiary cleft repair (horizontal,
vertical or both)), the difference in patient reported outcomes measurements
(PROM) before and after implantation of an dental implant and evaluation of the
periodontal parameters (pocket depth (PD), bleeding on probing (BoP) and a
standardized intraoral radiograph).
Study design
Cohort study
Study burden and risks
This study is a non-interventional study comparing results from a standard
procedure between two groups. The procedure has been used in standard of care
and all used devices are CE-marked, therefore the patients are not in any risk
other than the procedure they would be having anyway, and a structured risk
analysis is not deemed necessary. The patients will be visiting once. During
this visit a calibrated periodontal probe will be used to measure BoP and PD, a
radiograph of the implant will be taken using a standardized method and PROM
will be measured using the Dutch translation of the Oral Health Impact Profile
(OHIP- NL49).
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
1. At least 18 years old.
2. Has been treated for cleft condition.
3. Received a dental implant in replacement of one or more of the maxillary
incisors or canine.
Exclusion criteria
1. Disability (mental and/or physical) to maintain basic oral hygiene procedures
2. Condition which affects the healing of bone.
3. Patients unwilling or incapable of understanding and signing the informed
consent for secondary measurements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74784.078.20 |