Periodontitis Clinical Trial
Official title:
The Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects - a Multi-center Randomized Controlled Trial
The aim of this randomized clinical trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone? 200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree >I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | March 1, 2036 |
Est. primary completion date | March 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Patients should present with at least one surgically accessible molar (in tooth position 6 or 7) diagnosed with a single furcation defect degree II (at any aspect). Following initial periodontal therapy, teeth to be included should present with one site with furcation defect degree II in combination with: - Bleeding on probing - Probing pocket depth of =6 mm - Soft tissue coverage of the furcation entrance Patients should present with a full mouth plaque score =25%. Exclusion Criteria: - Multiple deep furcation defects (degree II - III) at the same tooth - Vertical attachment loss >50% at aspects not facing the furcation defect - Defects presenting with apico-marginal communication - Intake of systemic antibiotics within 6 months - Systemic conditions/medication impeding surgical intervention (e.g. uncontrolled diabetes, immunosuppressive medication) |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Periodontology, Institute of Odontology | Göteborg |
Lead Sponsor | Collaborator |
---|---|
Göteborg University | Charite University, Berlin, Germany, Geistlich Pharma AG, Johann Wolfgang Goethe University Hospital, King's College London, Queen Mary University of London, Vastra Gotaland Region |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients/teeth displaying furcation closure. | Furcation closure defined as absence of clinically detectable furcation involvement degree >I. | 6 months. | |
Primary | Proportion of patients/teeth displaying furcation closure. | Furcation closure defined as absence of clinically detectable furcation involvement degree >I. | 12 months. | |
Primary | Proportion of patients/teeth displaying furcation closure. | Furcation closure defined as absence of clinically detectable furcation involvement degree >I. | 3 years. | |
Primary | Proportion of patients/teeth displaying furcation closure. | Furcation closure defined as absence of clinically detectable furcation involvement degree >I. | 5 years. | |
Primary | Proportion of patients/teeth displaying furcation closure. | Furcation closure defined as absence of clinically detectable furcation involvement degree >I. | 7 years. | |
Primary | Proportion of patients/teeth displaying furcation closure. | Furcation closure defined as absence of clinically detectable furcation involvement degree >I. | 10 years. | |
Secondary | Changes in probing pocket depth. | Reductions in PPD relative to baseline. | 6 months. | |
Secondary | Changes in probing pocket depth. | Reductions in PPD relative to baseline. | 12 months. | |
Secondary | Changes in probing pocket depth. | Reductions in PPD relative to baseline. | 3 years. | |
Secondary | Changes in probing pocket depth. | Reductions in PPD relative to baseline. | 5 years. | |
Secondary | Changes in probing pocket depth. | Reductions in PPD relative to baseline. | 7 years. | |
Secondary | Changes in probing pocket depth. | Reductions in PPD relative to baseline. | 10 years. | |
Secondary | Changes in bleeding on probing. | Reductions in BOP relative to baseline. | 6 months. | |
Secondary | Changes in bleeding on probing. | Reductions in BOP relative to baseline. | 12 months. | |
Secondary | Changes in bleeding on probing. | Reductions in BOP relative to baseline. | 3 years. | |
Secondary | Changes in bleeding on probing. | Reductions in BOP relative to baseline. | 5 years. | |
Secondary | Changes in bleeding on probing. | Reductions in BOP relative to baseline. | 7 years. | |
Secondary | Changes in bleeding on probing. | Reductions in BOP relative to baseline. | 10 years. | |
Secondary | Changes in vertical and horizontal clinical attachment level. | Changes in clinical attachment levels relative to baseline. | 6 months. | |
Secondary | Changes in vertical and horizontal clinical attachment level. | Changes in clinical attachment levels relative to baseline. | 12 months. | |
Secondary | Changes in vertical and horizontal clinical attachment level. | Changes in clinical attachment levels relative to baseline. | 3 years. | |
Secondary | Changes in vertical and horizontal clinical attachment level. | Changes in clinical attachment levels relative to baseline. | 5 years. | |
Secondary | Changes in vertical and horizontal clinical attachment level. | Changes in clinical attachment levels relative to baseline. | 7 years. | |
Secondary | Changes in vertical and horizontal clinical attachment level. | Changes in clinical attachment levels relative to baseline. | 10 years. | |
Secondary | Changes in marginal soft tissue levels. | Changes in marginal soft tissue levels relative to baseline. | 6 months. | |
Secondary | Changes in marginal soft tissue levels. | Changes in marginal soft tissue levels relative to baseline. | 12 months. | |
Secondary | Changes in marginal soft tissue levels. | Changes in marginal soft tissue levels relative to baseline. | 3 years. | |
Secondary | Changes in marginal soft tissue levels. | Changes in marginal soft tissue levels relative to baseline. | 5 years. | |
Secondary | Changes in marginal soft tissue levels. | Changes in marginal soft tissue levels relative to baseline. | 7 years. | |
Secondary | Changes in marginal soft tissue levels. | Changes in marginal soft tissue levels relative to baseline. | 10 years. | |
Secondary | Changes in radiographic bone levels. | Changes in radiographic bone levels relative to baseline. | 12 months. | |
Secondary | Changes in radiographic bone levels. | Changes in radiographic bone levels relative to baseline. | 3 years. | |
Secondary | Changes in radiographic bone levels. | Changes in radiographic bone levels relative to baseline. | 5 years. | |
Secondary | Changes in radiographic bone levels. | Changes in radiographic bone levels relative to baseline. | 10 years. | |
Secondary | Patient satisfaction assessed by visual analogue scale. | Patient satisfaction as assessed on a 100 mm VAS. | 6 months. | |
Secondary | Patient satisfaction assessed by visual analogue scale. | Patient satisfaction as assessed on a 100 mm VAS. | 12 months. | |
Secondary | Patient discomfort as expressed on a visual analogue scale. | Patient discomfort following surgical therapy as expressed on a 100 mm VAS. | 2 weeks. | |
Secondary | Patient discomfort as expressed on a visual analogue scale. | Patient discomfort following surgical therapy as expressed on a 100 mm VAS. | 6 months. | |
Secondary | Esthetic appreciation as expressed on a visual analogue scale. | Esthetic appreciation as expressed on a 100 mm VAS. | 6 months. | |
Secondary | Esthetic appreciation as expressed on a visual analogue scale. | Esthetic appreciation as expressed on a 100 mm VAS. | 12 months. | |
Secondary | Rate of adverse events. | Impaired healing following surgical intervention. | 2 weeks. | |
Secondary | Rate of adverse events. | Impaired healing following surgical intervention. | 12 months. | |
Secondary | Tooth loss. | Event of tooth loss during follow-up. | 12 months. | |
Secondary | Tooth loss. | Event of tooth loss during follow-up. | 3 years. | |
Secondary | Tooth loss. | Event of tooth loss during follow-up. | 5 years. | |
Secondary | Tooth loss. | Event of tooth loss during follow-up. | 7 years. | |
Secondary | Tooth loss. | Event of tooth loss during follow-up. | 10 years. | |
Secondary | Need for retreatment. | Need for surgical retreatment of included site. | 12 months. | |
Secondary | Need for retreatment. | Need for surgical retreatment of included site. | 3 years. | |
Secondary | Need for retreatment. | Need for surgical retreatment of included site. | 5 years. | |
Secondary | Need for retreatment. | Need for surgical retreatment of included site. | 7 years. | |
Secondary | Need for retreatment. | Need for surgical retreatment of included site. | 10 years. | |
Secondary | Change of inflammatory markers. | Change of inflammatory markers measured in gingival crevicular fluid. | 2 weeks. | |
Secondary | Change of inflammatory markers. | Change of inflammatory markers measured in gingival crevicular fluid. | 6 weeks. |
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