Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029322
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-08-31
Brief Title:
A Comparative Clinical Study Between a Collagen Matrix and Collagen Membrane As Wound Protection During Ridge Preservation ARP
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Collagen Matrix to Collagen Membrane As Socket Seal in Alveolar Ridge Preservation
Status:
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:
ARP
Brief Summary:
Patients in need of extraction of two teeth in combination with alveolar ridge preservation will be invited to participate in intra-subject RCT on ARP Prior to surgery a small-field low-dose CBCT is taken
18 patients will be included each contributing 1 surgical site to each treatment arm
Since this study is a intra-subject RCT randomization of the surgical site will be performed just after ARP by a coin flip Randomization is concealed for the evaluating examiner and statistician
After ARP the collagen matrix or collagen membrane is used to seal the coronal aspect of the extraction socket
Soft tissue thickness in centre of the site will be determined using CBCT Secondary outcomes include Wound dimensions socket wound healing score changes in bone and soft tissue dimensions and changes in buccal soft tissue profile
18 patients will be included each contributing 1 surgical site to each treatment arm
Since this study is a intra-subject RCT randomization of the surgical site will be performed just after ARP by a coin flip Randomization is concealed for the evaluating examiner and statistician
After ARP the collagen matrix or collagen membrane is used to seal the coronal aspect of the extraction socket
Soft tissue thickness in centre of the site will be determined using CBCT Secondary outcomes include Wound dimensions socket wound healing score changes in bone and soft tissue dimensions and changes in buccal soft tissue profile
Detailed Description:
The primary study objective is to compare soft tissue thickness in the centre of the site between collagen matrix and collagen membrane at 4 months following ARP
Secondary study outcomes relate to the same comparison and include the following variables wound reduction after 7 days and 21 days socket wound healing score after 7 days 21 days and 4 months changes in bone and soft tissue dimensions including soft tissue profile between pre-op and 4 months
Patients will be included in an intra-subject RCT on ARP following screening and written consent at the Department of Periodontology and Oral Implantology of the University Hospital in Ghent
A sample size calculation was performed in SPSS Statistics 28 IBM New York USA using the paired samples t-test The calculation was based on finding a mean difference of 05 mm in the final soft tissue thickness between test and control sites with a standard deviation of 06 mm Eeckhout et al 2022 With alpha set at 005 and a power of 008 the sample size calculation indicated 14 patients to be included To compensate for possible dropouts this number was increased to 18 patients
Randomization allocation concealment and blinding Since this is an intra-subject RCT every patient receives the test treatment as well as the control treatment A coin flip will determine which site in each patient is treated with the collagen matrix test site and which one with the collagen membrane control site Group allocation will be determined just after ARP and remains concealed for the evaluating examiner and statistician to allow for unbiased registrations and analyses respectively
Treatment procedures and postoperative care Patients will be instructed to take systemic antibiotics amoxicilline 2g and anti-inflammatory medication ibuprofen 600 mg 1 h pre-operatively Just prior to the treatment patients rinse with a 012 chlorhexidine solution Perio-aid Intensive Care Dent-Aid Benelux Houten The Netherlands and local anesthesia Septanest special noradrenaline 1100000 Septodont Saint Maur des Fossés France will be administered
Teeth are preferably extracted without flap elevation When deemed necessary by the clinician papillary incisions can be made for minimal reflection which enables to place elevators without damaging soft tissues Buccal soft tissues must never be raised Following wound debridement and rinsing the amount of missing bone is measured with a periodontal probe to the nearest 05 mm Missing buccal bone is defined as the vertical distance between the buccal bone crest and the midfacial soft tissue margin minus 3 mm Then both alveolar sockets are filled with collagen-enriched deproteinized bovine bone mineral C-DBBM Bio-Oss Collagen 100 mg or 250 mg Geistlich Pharma AG Wolhusen Switzerland up to the level of the lingual bone crest The same procedure is performed for intact and non-intact alveoli Thereupon a coin will be flipped to determine the assignment for either one of two treatment modalities to each site
Test site collagen matrix Mucograft Seal Geistlich Pharma AG Wolhusen Switzerland
Control site collagen membrane BioGide Compressed 13x25 mm Geistlich Pharma AG Wolhusen Switzerland At the control site a small pouch is made at the buccal and lingual aspect in order to place the membrane The socket seal material is sutured with at least 4 single sutures Seralon 60 Serag Weissner Naila Germany to protect the underlying C-DBBM Care is taken to ensure perfect approximation between the wound margins and the socket seal material
Systemic antibiotics amoxicilline 2g will be continued for 4 days and anti-inflammatory medication ibuprofen 600 mg is taken as deemed necessary by the patient Patients rinse with a 012 chlorhexidine solution twice daily for 1 week Then sutures are removed
Primary outcome soft tissue thickness in the centre of the site Soft tissue thickness in the centre of the site will be assessed using the method of Seyssens et al 2019 A small-field low-dose CBCT image is taken at T0 immediately postop and T3 4 months All CBCT images will be obtained using a ProMax 3D Max device Planmeca Helsinki Finland with the same standardized settings 90 kV 63 mA 9 seconds voxel size 200 μm with a same field of view 50 80 mm for each patient Lip retractors are used to clearly visualize the external soft tissue profile and patients will be instructed to fold the tongue backwards for the same reason Using specialized software Invivo6 Osteoid Inc Santa Clara California United States both CBCT images are superimposed First a reference line is drawn on the postoperative CBCT T0 at the level of the long axis of the extracted tooth Then the software switch to the superimposed CBCT T3 while keeping this reference line Soft tissue thickness in the centre of the site will be measured on the reference line as the vertical distance between the alveolar proces and the soft tissue outline
Bucco-lingual and mesio-distal wound dimensions These are registered with a periodontal probe to the nearest 05 mm at T0 immediately postop T1 1 week and T2 3 weeks
Socket Wound Healing Score SWHS SWHS Afat et al 2019 is assessed at T1 1 week T2 3 weeks and T3 4 months SWHS is used to evaluate wound dehiscence epithelialization quality of granulation tissue filling the post-extraction socket and depth between early granulation tissue and wound margin SWHS is assessed on the basis of occlusal clinical pictures and results in the following scores 0 Wound covered with keratinized gingiva pink tissue color no bleeding continuous with healthy tissue 1 Socket filled with organized granulation tissue no bleeding collapsed to a depth of 0 - 2 mm from the buccal gingival margin 2 Socket filled with organized granulation tissue ¼ to ½ of the wound showing red tissue color no bleeding collapsed to a depth of 2 - 4 mm from the buccal gingival margin 3 Socket filled with unorganized granulation tissue more than ½ of the wound showing red tissue color bleeding no evidence of acute infection 4 Socket is filled with foreign material food etc and shows signs of alveolitis
Changes in bone and soft tissue dimensions These will also be assessed on the same CBCT images taken at T0 immediately postop and T3 4 months Using specialized software Invivo6 Osteoid Inc Santa Clara California United States both CBCT images are superimposed The following reference lines will be constructed on the postoperative CBCT T0 in the centre of the extracted tooth the long axis of the extracted tooth the level of the lingual bone crest perpendicular to the long axis of the extracted tooth level -1 mm level -3 mm and level -5 mm apical to the lingual bone crest and perpendicular to the long axis of the extracted tooth Bone width is registered at the three levels -1 -3 and -5 mm Buccal and lingual soft tissue height is measured as the vertical distance between the alveolar process and the soft tissue outline parallel to the vertical reference line at the most buccal and lingual part of the alveolar process After completing all measurements on the postoperative CBCT the software changes to the superimposed CBCT T3 image so that the same measurements can be done while all keeping all reference lines Finally changes will be calculated by subtracting the measurements at T3 from the measurements at T0
Changes in buccal soft tissue profile An intra-oral scan Trios 3shape Copenhagen Denmark will be taken at T0 immediately postop and T3 4 months The obtained digital surface models in STL Surface Tessellation Language format will be imported into designated software SMOP Swissmeda AG Zurich Switzerland to analyze profilometric changes A study-relevant area of interest AOI at the buccal aspect is selected for each site The AOI reaches from 05 mm below the soft tissue margin to 4 mm more apical In mesiodistal dimension the AOI reaches from the mesial to the distal line angle The AOI varies between sites due to individual anatomic differences but will be kept constant in each site across timepoints Digital surface models are superimposed using the best-fit algorithm at the unchanged adjacent tooth surfaces A mean volumetric change mm3 within the AOI for each site from T0 to T3 is calculated by the software and divided by the AOI resulting in a mean change in buccal soft tissue profile Details on the method can be found in an earlier paper Eeckhout et al 2020
Statistical analysis SPSS Statistics 28 IBM New York USA will be used for data analysis Mean values standard deviations and 95 confidence intervals CIs will be calculated per treatment group The paired samples t-test is used to compare test and control sites at 4 months in terms of soft tissue thickness in the centre of the site and buccal soft tissue profile
A linear mixed model will be used to analyze the other secondary outcomes horizontal buccal bone loss at the different levels buccal and lingual soft tissue height wound dimensions and SWHS Treatment group time and their interaction will be modeled as fixed factors Patient and tooth position as random factors Estimated marginal means and 95 CIs will be calculated per treatment group and per timepoint The level of significance is set at 005
Secondary study outcomes relate to the same comparison and include the following variables wound reduction after 7 days and 21 days socket wound healing score after 7 days 21 days and 4 months changes in bone and soft tissue dimensions including soft tissue profile between pre-op and 4 months
Patients will be included in an intra-subject RCT on ARP following screening and written consent at the Department of Periodontology and Oral Implantology of the University Hospital in Ghent
A sample size calculation was performed in SPSS Statistics 28 IBM New York USA using the paired samples t-test The calculation was based on finding a mean difference of 05 mm in the final soft tissue thickness between test and control sites with a standard deviation of 06 mm Eeckhout et al 2022 With alpha set at 005 and a power of 008 the sample size calculation indicated 14 patients to be included To compensate for possible dropouts this number was increased to 18 patients
Randomization allocation concealment and blinding Since this is an intra-subject RCT every patient receives the test treatment as well as the control treatment A coin flip will determine which site in each patient is treated with the collagen matrix test site and which one with the collagen membrane control site Group allocation will be determined just after ARP and remains concealed for the evaluating examiner and statistician to allow for unbiased registrations and analyses respectively
Treatment procedures and postoperative care Patients will be instructed to take systemic antibiotics amoxicilline 2g and anti-inflammatory medication ibuprofen 600 mg 1 h pre-operatively Just prior to the treatment patients rinse with a 012 chlorhexidine solution Perio-aid Intensive Care Dent-Aid Benelux Houten The Netherlands and local anesthesia Septanest special noradrenaline 1100000 Septodont Saint Maur des Fossés France will be administered
Teeth are preferably extracted without flap elevation When deemed necessary by the clinician papillary incisions can be made for minimal reflection which enables to place elevators without damaging soft tissues Buccal soft tissues must never be raised Following wound debridement and rinsing the amount of missing bone is measured with a periodontal probe to the nearest 05 mm Missing buccal bone is defined as the vertical distance between the buccal bone crest and the midfacial soft tissue margin minus 3 mm Then both alveolar sockets are filled with collagen-enriched deproteinized bovine bone mineral C-DBBM Bio-Oss Collagen 100 mg or 250 mg Geistlich Pharma AG Wolhusen Switzerland up to the level of the lingual bone crest The same procedure is performed for intact and non-intact alveoli Thereupon a coin will be flipped to determine the assignment for either one of two treatment modalities to each site
Test site collagen matrix Mucograft Seal Geistlich Pharma AG Wolhusen Switzerland
Control site collagen membrane BioGide Compressed 13x25 mm Geistlich Pharma AG Wolhusen Switzerland At the control site a small pouch is made at the buccal and lingual aspect in order to place the membrane The socket seal material is sutured with at least 4 single sutures Seralon 60 Serag Weissner Naila Germany to protect the underlying C-DBBM Care is taken to ensure perfect approximation between the wound margins and the socket seal material
Systemic antibiotics amoxicilline 2g will be continued for 4 days and anti-inflammatory medication ibuprofen 600 mg is taken as deemed necessary by the patient Patients rinse with a 012 chlorhexidine solution twice daily for 1 week Then sutures are removed
Primary outcome soft tissue thickness in the centre of the site Soft tissue thickness in the centre of the site will be assessed using the method of Seyssens et al 2019 A small-field low-dose CBCT image is taken at T0 immediately postop and T3 4 months All CBCT images will be obtained using a ProMax 3D Max device Planmeca Helsinki Finland with the same standardized settings 90 kV 63 mA 9 seconds voxel size 200 μm with a same field of view 50 80 mm for each patient Lip retractors are used to clearly visualize the external soft tissue profile and patients will be instructed to fold the tongue backwards for the same reason Using specialized software Invivo6 Osteoid Inc Santa Clara California United States both CBCT images are superimposed First a reference line is drawn on the postoperative CBCT T0 at the level of the long axis of the extracted tooth Then the software switch to the superimposed CBCT T3 while keeping this reference line Soft tissue thickness in the centre of the site will be measured on the reference line as the vertical distance between the alveolar proces and the soft tissue outline
Bucco-lingual and mesio-distal wound dimensions These are registered with a periodontal probe to the nearest 05 mm at T0 immediately postop T1 1 week and T2 3 weeks
Socket Wound Healing Score SWHS SWHS Afat et al 2019 is assessed at T1 1 week T2 3 weeks and T3 4 months SWHS is used to evaluate wound dehiscence epithelialization quality of granulation tissue filling the post-extraction socket and depth between early granulation tissue and wound margin SWHS is assessed on the basis of occlusal clinical pictures and results in the following scores 0 Wound covered with keratinized gingiva pink tissue color no bleeding continuous with healthy tissue 1 Socket filled with organized granulation tissue no bleeding collapsed to a depth of 0 - 2 mm from the buccal gingival margin 2 Socket filled with organized granulation tissue ¼ to ½ of the wound showing red tissue color no bleeding collapsed to a depth of 2 - 4 mm from the buccal gingival margin 3 Socket filled with unorganized granulation tissue more than ½ of the wound showing red tissue color bleeding no evidence of acute infection 4 Socket is filled with foreign material food etc and shows signs of alveolitis
Changes in bone and soft tissue dimensions These will also be assessed on the same CBCT images taken at T0 immediately postop and T3 4 months Using specialized software Invivo6 Osteoid Inc Santa Clara California United States both CBCT images are superimposed The following reference lines will be constructed on the postoperative CBCT T0 in the centre of the extracted tooth the long axis of the extracted tooth the level of the lingual bone crest perpendicular to the long axis of the extracted tooth level -1 mm level -3 mm and level -5 mm apical to the lingual bone crest and perpendicular to the long axis of the extracted tooth Bone width is registered at the three levels -1 -3 and -5 mm Buccal and lingual soft tissue height is measured as the vertical distance between the alveolar process and the soft tissue outline parallel to the vertical reference line at the most buccal and lingual part of the alveolar process After completing all measurements on the postoperative CBCT the software changes to the superimposed CBCT T3 image so that the same measurements can be done while all keeping all reference lines Finally changes will be calculated by subtracting the measurements at T3 from the measurements at T0
Changes in buccal soft tissue profile An intra-oral scan Trios 3shape Copenhagen Denmark will be taken at T0 immediately postop and T3 4 months The obtained digital surface models in STL Surface Tessellation Language format will be imported into designated software SMOP Swissmeda AG Zurich Switzerland to analyze profilometric changes A study-relevant area of interest AOI at the buccal aspect is selected for each site The AOI reaches from 05 mm below the soft tissue margin to 4 mm more apical In mesiodistal dimension the AOI reaches from the mesial to the distal line angle The AOI varies between sites due to individual anatomic differences but will be kept constant in each site across timepoints Digital surface models are superimposed using the best-fit algorithm at the unchanged adjacent tooth surfaces A mean volumetric change mm3 within the AOI for each site from T0 to T3 is calculated by the software and divided by the AOI resulting in a mean change in buccal soft tissue profile Details on the method can be found in an earlier paper Eeckhout et al 2020
Statistical analysis SPSS Statistics 28 IBM New York USA will be used for data analysis Mean values standard deviations and 95 confidence intervals CIs will be calculated per treatment group The paired samples t-test is used to compare test and control sites at 4 months in terms of soft tissue thickness in the centre of the site and buccal soft tissue profile
A linear mixed model will be used to analyze the other secondary outcomes horizontal buccal bone loss at the different levels buccal and lingual soft tissue height wound dimensions and SWHS Treatment group time and their interaction will be modeled as fixed factors Patient and tooth position as random factors Estimated marginal means and 95 CIs will be calculated per treatment group and per timepoint The level of significance is set at 005
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?:
None
Is an FDA AA801 Violation?:
None