A Phase 4 interventional study of Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) and Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) in Furcation Defects and Periodontal Diseases, sponsored by University of Oslo. Terminated at 1 site in Norway. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by University of Oslo · Phase 4, Interventional, and Treatment
Teeth with furcation grade III defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.
42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.
This study's enrollment of 5 is below the median of 27 across 38 interventional studies indexed under Furcation Defects.
Browse Furcation Defects studies →University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The following must not be present at the time of enrolment;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.
Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) · Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.
Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) · Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + collagen membrane.
Drug page: Enamel matrix proteins
Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + enamel matrix proteins.
Change of furcation grade level
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
Time frame: 12 months after treatment
Change of furcation grade level
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
Time frame: 24 months after treatment
Changes in patient-reported quality of life (QoL)
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected, (2) less than once a month, (3) once or twice a month, (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected, including category (1).
Time frame: Preoperatively compared to 24 months after treatment
Changes in patient-reported quality of life (QoL)
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected, (2) less than once a month, (3) once or twice a month, (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected, including category (1).
Time frame: Preoperatively compared to 12 months after treatment
Changes in defect morphology assessed by CBCT
Cone beam computed tomography will be acquired at baseline, 2 weeks postoperatively and 24 months postoperatively. This outcome measures quantitative morphologic changes in the furcation defects at 24 months
Time frame: 24 months after treatment
Changes in pocket probing depth
Changes in pocket probing depth will be measured with a probe
Time frame: 12 months after treatment
Changes in pocket probing depth
Changes in pocket probing depth will be measured with a probe
Time frame: 24 months after treatment
Changes in PPD
Changes in pocket probing depth will be measured with a probe
Time frame: 12 months after treatment
Changes in PPD
Changes in pocket probing depth will be measured with a probe
Time frame: 24 months after treatment
Radiographic changes
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Time frame: 12 months after treatment
Radiographic changes
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Time frame: 24 months after treatment
Pain following surgery
Pain sensation one week posteoperatively will be recorded on a visual analog scale from 0-10. 0 means no pain sensation, whereas 10 means highest pain imagineable.
Time frame: Up to 1 week postoperatively
Caries assessment
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Time frame: 24 months
Caries assessment
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Time frame: 12 months
Plan to share: Undecided
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This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Enamel matrix proteins