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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.

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. - Class II furcation treated with BDX plus collagen membrane or BDX alone

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30137
Enrollment
40
Registered
2007-08-07
Start date
2007-01-01
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

parodontologie Bone loss in between two roots of a molar Furcation defect

Interventions

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

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Efficacy of therapy will be described by change of horizontal probing bone level measurements (HPBL) as primary parameter.

Secondary

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)