Investigation of the influence of gingival biotype on the aesthetics and manipulation of the gingival biotype in order to convert a thin biotype into a thick biotype by application of a connective tissue graft or a synthetic graft material in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Tandheelkundige implantologie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in mid-facial soft tissue level from
placement to 18 months thereafter.
Secondary outcome
- Aesthetics of the soft and hard tissue
- Implant survival
- Clinical peri-implant variables
- Change in volume labial gingival
- Change in bone resorption
- Patient satisfaction
Background summary
The application of dental implants for single-tooth replacements in the
maxillofacial aesthetic zone has evolved into a viable prosthodontic
alternative to conventional fixed bridgework, resin-bonded restorations or
removable partial dentures. Because of the high levels of survival, the focus
of attention is moving from *survival* to *quality of survival* and the
aesthetics are becoming the measure of success. The peri-implant soft tissue
plays an important role. This involves the establishment of a soft tissue
contour that is harmonious with the gingiva of the adjacent teeth.
Unfortunately, a major concern in achieving harmonious aesthetics and an
aesthetic final result is the peri-implant soft tissue recession of the
mid-buccal mucosa after placing an implant.
According to several authors the aesthetic success of implant placement in
terms of soft tissue recession is dependent on the gingival biotype. A thin
gingival biotype is said to be more prone to recession of the mid-facial
peri-implant mucosa. A thick biotype is said to result in a more predictable
and satisfactory aesthetic result in harmony with neighbouring teeth.
Connective tissue grafting in combination with single implant placement and
immediate provisionalization is reported to be able to convert a thin gingival
biotype into a thick gingival biotype and in this way influencing
predictability of the aesthetic outcome.
However, this type of treatment has been evaluated scarcely in combination with
single tooth replacement and evidence from a randomized controlled clinical
trial is missing.
Study objective
Investigation of the influence of gingival biotype on the aesthetics and
manipulation of the gingival biotype in order to convert a thin biotype into a
thick biotype by application of a connective tissue graft or a synthetic graft
material in combination with a single implant placement.
Study design
A single blinded, randomized clinical trial.
Intervention
For this study a single implant is placed in the extraction wound or in healed
extraction sites and immediately restored with a screw-retained temporary
crown. Depending on the studygroup the mid-buccal mucosa is manipulated by a
autologous or synthetic tissue graft.
Study burden and risks
All patients have three additional research appointments. During these
appointments digital intra-oral pictures and impressions are taken.
Furthermore an intra oral examination of the peri-implant mucosa is done and
the patients are asked to fill out a questionnaire.
Poortweg 2
Groningen 9713 AV
NL
Poortweg 2
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
- The patient is 18 years or older;
- The missing tooth, lost tooth or about to loose tooth is an incisor (central or lateral), a canine or a first premolar in the maxilla; the adjacent teeth are natural teeth;
- Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter;
- The implant site must be free from infection;
- Adequate oral hygiene (modified plaque index and modified sulcus bleeding index <= 1);
- Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
- The temporary restoration can be designed free from occlusal contact;
- The patient is capable of understanding and giving informed consent.
Exclusion criteria
- Medical and general contraindications for the surgical procedures;
- Presence of an active and uncontrolled periodontal disease;
- Presence of pathologic microflora;
- Bruxism;
- Site of implant placement is an extraction wound younger than three months;
- Smoking (patients who stop smoking six weeks before the operation can be included);
- A history of local radiotherapy to the head and neck region.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL43085.042.13 |
| Other | TC 3815 |
| OMON | NL-OMON25914 |