Up to now there are only very limited data from clinical studies available comparing treatment of mandibular class II furcation defects with various types of particulate graft materials in combination with GTR to the treatment with such a graft…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
parodontologie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy of therapy will be described by change of horizontal probing bone
level measurements (HPBL) as primary parameter.
Secondary outcome
Secondary study parameters are full-mouth plaque scores (FMPS), full-mouth
bleeding on probing scores (FMBS), site plaque score (SPS), site bleeding on
probing score (SBS), probing pocket depth (PPD), clinical attachment level
(CAL), recession (REC), horizontal probing depth (HPD), vertical probing bone
level measurement (VPBL), vertical open bone level measurement (VOBL), and
horizontal open bone level measurement (HOBL).
Background summary
Titel:
A randomized, controlled clinical trial comparing treatment of buccal class II
furcation defects in mandibular molars with a bovine derived xenograft
(Tutodent® microchips [Tutogen, Neunkirchen am Brand, Germany]) in combination
with a bovine derived collagen membrane (Tutodent® membrane [Tutogen,
Neunkirchen am Brand, Germany] to treatment with a bovine derived xenograft
(Tutodent® microchips [Tutogen, Neunkirchen am Brand, Germany]) alone.
Background:
Molar teeth with furcation involvement respond less favorably to conventional
periodontal therapy than molar teeth without furcation involvement or non-molar
teeth. Therefore furcation involvement presents one of the greatest challenges
in periodontal therapy. Available data from the literature suggests that
treatment of mandibular class II furcation defects by means of a particulate
graft material combined with GTR could result in additional clinical
improvements compared to treatment with GTR alone.
Study objective
Up to now there are only very limited data from clinical studies available
comparing treatment of mandibular class II furcation defects with various types
of particulate graft materials in combination with GTR to the treatment with
such a graft material alone. In particular, there are no data available from
controlled clinical studies evaluating the healing of buccal mandibular class
II furcation defects following treatment with Tutodent® microchips in
combination with the Tutodent® membrane compared to treatment with Tutodent®
microchips alone.
Moreover, it is unknown if the treatment outcome with Tutodent® microchips in
combination with the Tutodent® membrane is superior to that with Tutodent®
microchips alone.
Therefore, the aim of this study is to assess the effect of treatment of buccal
class II furcation defects in mandibular molars with a bovine derived xenograft
(Tutodent® microchips) in combination with a bovine derived collagen membrane
(Tutodent® membrane to treatment with a bovine derived xenograft (Tutodent®
microchips) alone.
Study design
Multicentre study with an examiner-blinded parallel arm randomized design.
Intervention
Periodontal regenerative surgery. The furcation defects will be randomly
treated with a bovine derived xenograft (Tutodent® microchips [Tutogen,
Neunkirchen am Brand, Germany]) in combination with a bovine derived collagen
membrane (Tutodent® membrane [Tutogen, Neunkirchen am Brand, Germany] or
treated with a bovine derived xenograft (Tutodent® microchips [Tutogen,
Neunkirchen am Brand, Germany]) alone.
Study burden and risks
The therapies used are standard therapies, therefore risks with participation,
and benefit are not different for patients included in the study compared to
patients treated in this way outside the study.
Philips van Leydenlaan 25
6525 EX Nijmegen
Nederland
Philips van Leydenlaan 25
6525 EX Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Periodontitis patients, diagnosed with chronic periodontitis, having reached at least the first re-evaluation time point after the initial phase of periodontal therapy.
All patients will have buccal class II furcation involvement in mandibular first or second molars.
Exclusion criteria
Beside the threshold levels decided for FMPS (25%) and FMBS (25%), patients will not be included in this study, (1) if they are systemically not healthy (that is, having any systemic condition that precludes periodontal surgery, or that might compromise wound healing), (2) if not diagnosed with chronic periodontitis, (3) treated with antibiotics within 3 months prior to surgery, (4) current smokers, and (5) involved in any other clinical trial. On a site level, the selected lower first or second molars will have (1) mandibular buccal class II furcation involvement (HPD > 3 mm), (2) proximal bone levels at or above the fornix of the furcation, and (3) a zone of keratinized tissue of at least 2 mm adjacent to the furcation defect, in order to provide coverage of the furcation entrance during surgery. If, (4) a root canal treatment was performed, the selected tooth must be asymptomatic and the root canal treatment must be without technical remarks, and (5) such a root canal treatment must be completed at least six months before the selected tooth is enrolled in the study. Teeth will be excluded from the study, if (1) buccal restorations extend to the furcation area in a way that the margins of these restorations are less than 1 mm away from the entrance of the furcation, (2) they have in addition lingual class II furcation involvement (HPD > 3 mm), (3) they are non-vital and have posts or screw retentive devices, (4) they are non-vital and are not endodontically treated, (5) furcation class III involvement is revealed during surgery, or (6) they have enamel projections into the furcation defect not being removable during surgery.
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 | NL12797.091.06 |