Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-13
Brief Title:
Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
The Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects - a Multi-center Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
The study will be conducted as a randomized controlled trial with a 12-month follow-up at multiple clinical centers throughout Europe All study-related procedures are to be performed by specialists in periodontics or clinicians in specialist training 200 patients with 1 molar with a furcation defect degree II pre-surgical assessment will be enrolled in the study Following the primary evaluation at 12 months study participants will be followed up to 10 years
Preparatory phase Prior to surgery patients will be provided with tailored non-surgical periodontal therapy including instructions in self-performed plaque control measures and supra- and subgingival instrumentation The preparatory phase is concluded by an examination 8-16 weeks after completion of the non-surgical instrumentation
Surgical intervention Following local anesthesia full thickness flaps at target molars will be elevated and inflamed tissues are removed Root surfaces are then instrumented using an ultra-sonic device with a standardized tip under irrigation with saline Upon completion of root instrumentation group allocation is revealed and a bone substitute material will be placed in the furcation defect to the level of the outer contour of the roots in the test group Flaps will be repositioned and sutured to cover the entirety of the furcation area aiming for primary closure The same procedure omitting the placement of the bone substitute material will be performed in the control group
Patients will refrain from mechanical self-performed plaque control measures in the surgical area for 4 weeks post-surgery During this period daily rinsing with a 02 solution of chlorhexidine digluconate is prescribed
Follow-up Sutures will be removed after two weeks and patient-reported experience PRE is scored Patients will then be seen for oral hygiene instructions at 4 weeks and for supportive periodontal therapy at 3 6 9 and 12 months Treatment and patient-reported outcomes PROs will be evaluated at 6 and 12 months Additional examinations are carried out at 3 5 7 and 10 years
Clinical assessments Clinical examinations at baseline and during follow-up will be performed by calibrated and blinded examiners The following parameters will be recorded at all included teeth degree of furcation horizontal and vertical attachment levels Bleeding on probing and plaque yesno and probing pocket depth mm will be scored Soft tissue levels will be assessed relative to the cemento-enamel junction
During the surgical intervention dimensions of the furcation defect will be noted Adverse events will be noted
Radiographic assessments Standard intra-oral radiographs will be obtained at baseline at 12 months and at years 3 5 and 10 Assessments with regard to bone level changes and interradicular bone fill will be performed by an examiner blinded to group allocation
Biomarkers In a nested approach two centers Gothenburg London will perform evaluations of inflammatory markers during healing Prior to the surgical intervention and at 2 weeks 6 months and 12 months samples of gingival crevicular fluid GCF will be obtained GCF will be collected at the target site as well as the contra-lateral molar or alternative tooth if missing utilizing PerioPaper strips Inflammatory markers eg IL-1 IL-6 will be evaluated through ELISA
Questionnaire Patients will be asked to complete an assisted questionnaire at baseline as well as at 6 and 12 months PROs Questions addressing patient satisfaction and potential discomfort after treatment are answered by means of a visual analogue scale 10 cm Patient-reported experiences PREs will be scored at the 2-week control visit following the surgical intervention
Enrolment randomization group allocation and blinding Patients meeting the inclusion criteria following completion of the preparatory phase will be invited on a consecutive basis Upon signed consent participants are enrolled and assigned a unique identification number by which patients are randomly allocated to one of two study arms Randomization ratio 11 is performed by computer-generated lists with permuted blocks of eight and stratified for smoking Allocation is concealed by the use of opaque envelopes not opened until completion of the surgical debridement Examiners at baseline and during follow-up will be blinded to group allocation
Data analysis Categorical and continuous variables originating from the clinical radiographic and biomarker assessments will be evaluated by regression analyses adjusted for group allocation time point repeated measurements baseline 6 months 1 year etc smoking and toothfurcation location site 1st vs 2nd molar mandible vs maxilla An intention-to-treat approach will be followed It is assumed that drop-out will occur at random Hence latest available data points will be moved forward A potential center effect will be evaluated PROs are expected to be not-normally distributed and will be assessed through non-parametric methods
Preparatory phase Prior to surgery patients will be provided with tailored non-surgical periodontal therapy including instructions in self-performed plaque control measures and supra- and subgingival instrumentation The preparatory phase is concluded by an examination 8-16 weeks after completion of the non-surgical instrumentation
Surgical intervention Following local anesthesia full thickness flaps at target molars will be elevated and inflamed tissues are removed Root surfaces are then instrumented using an ultra-sonic device with a standardized tip under irrigation with saline Upon completion of root instrumentation group allocation is revealed and a bone substitute material will be placed in the furcation defect to the level of the outer contour of the roots in the test group Flaps will be repositioned and sutured to cover the entirety of the furcation area aiming for primary closure The same procedure omitting the placement of the bone substitute material will be performed in the control group
Patients will refrain from mechanical self-performed plaque control measures in the surgical area for 4 weeks post-surgery During this period daily rinsing with a 02 solution of chlorhexidine digluconate is prescribed
Follow-up Sutures will be removed after two weeks and patient-reported experience PRE is scored Patients will then be seen for oral hygiene instructions at 4 weeks and for supportive periodontal therapy at 3 6 9 and 12 months Treatment and patient-reported outcomes PROs will be evaluated at 6 and 12 months Additional examinations are carried out at 3 5 7 and 10 years
Clinical assessments Clinical examinations at baseline and during follow-up will be performed by calibrated and blinded examiners The following parameters will be recorded at all included teeth degree of furcation horizontal and vertical attachment levels Bleeding on probing and plaque yesno and probing pocket depth mm will be scored Soft tissue levels will be assessed relative to the cemento-enamel junction
During the surgical intervention dimensions of the furcation defect will be noted Adverse events will be noted
Radiographic assessments Standard intra-oral radiographs will be obtained at baseline at 12 months and at years 3 5 and 10 Assessments with regard to bone level changes and interradicular bone fill will be performed by an examiner blinded to group allocation
Biomarkers In a nested approach two centers Gothenburg London will perform evaluations of inflammatory markers during healing Prior to the surgical intervention and at 2 weeks 6 months and 12 months samples of gingival crevicular fluid GCF will be obtained GCF will be collected at the target site as well as the contra-lateral molar or alternative tooth if missing utilizing PerioPaper strips Inflammatory markers eg IL-1 IL-6 will be evaluated through ELISA
Questionnaire Patients will be asked to complete an assisted questionnaire at baseline as well as at 6 and 12 months PROs Questions addressing patient satisfaction and potential discomfort after treatment are answered by means of a visual analogue scale 10 cm Patient-reported experiences PREs will be scored at the 2-week control visit following the surgical intervention
Enrolment randomization group allocation and blinding Patients meeting the inclusion criteria following completion of the preparatory phase will be invited on a consecutive basis Upon signed consent participants are enrolled and assigned a unique identification number by which patients are randomly allocated to one of two study arms Randomization ratio 11 is performed by computer-generated lists with permuted blocks of eight and stratified for smoking Allocation is concealed by the use of opaque envelopes not opened until completion of the surgical debridement Examiners at baseline and during follow-up will be blinded to group allocation
Data analysis Categorical and continuous variables originating from the clinical radiographic and biomarker assessments will be evaluated by regression analyses adjusted for group allocation time point repeated measurements baseline 6 months 1 year etc smoking and toothfurcation location site 1st vs 2nd molar mandible vs maxilla An intention-to-treat approach will be followed It is assumed that drop-out will occur at random Hence latest available data points will be moved forward A potential center effect will be evaluated PROs are expected to be not-normally distributed and will be assessed through non-parametric methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None