Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05717478
Status:
RECRUITING
Last Update Posted:
2023-04-12
First Post:
2023-01-28
Brief Title:
Regeneration of Alveolar Sockets With rhBMP-2-loaded Bovine Bone Mineral
Sponsor:
Universidad Complutense de Madrid
Organization:
Universidad Complutense de Madrid
Study Overview
Official Title:
Post-extraction Bone Regeneration of Partially Destroyed Sockets With Bovine Hydroxyapatite and rhBMP-2 Compared to Standard Guided Bone Regeneration Intervention Bovine Hydroxyapatite and Collagen Membrane
Status:
RECRUITING
Status Verified Date:
2023-01
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:
PROTEOGRAFT
Brief Summary:
Aim of the present investigation will be to evaluate the efficacy and safety of a granulate of rhBMP-2- loaded bovine bone mineral rhBMP-2-BBM as alveolar bone regeneration procedure following tooth extraction
Forty 40 patients both sex age 18 years and older requiring extraction of one 1 hopeless tooth incisor canine or premolar with loss of bone height of 5 mm or more in buccal alveolar wall followed by alveolar bone regeneration ABR and placement of an endosteal implant will be enrolled into the study
After exodontia participants will be randomized and divided into two groups in Experimental Group the socket will be grafted with rhBMP-2-BBM granules 10-025 mm in Control Group the sockets will be grafted with Bio-Oss granules 10-025 mm and covered with porcine collagen barrier membrane Bio-Gide
The end of the study will be fixed at the implantation surgery seventeen 17 weeks after exodontia an ABR Cone beam computed tomography CBCT scans will be made immediately after 0 and sixteen 16 weeks after exodontia an ABR and the gain in alveolar bone height will be estimated and used as the primary outcome for comparison of both groups
As secondary efficacy outcomes the change in alveolar bone width estimated from the CBCT scans initial 0 and at seventeenth 17th week after tooth extraction the change in dental arch dimensions estimated from tridimensional models obtained from intraoral scans at one week before -1 and sixteen 16 weeks exodontia an ABR and the amounts of new bone remnant material and connective tissue histomorphometrically measured in a bone biopsy collected during the implantation surgery at seventeenth 17th week will be considered
Healing of gingival tissues at first 1st and second 2nd week and incidence of adverse reactions at first 1st second 2nd and sixteenth 16th week are used as secondary safety outcomes
Forty 40 patients both sex age 18 years and older requiring extraction of one 1 hopeless tooth incisor canine or premolar with loss of bone height of 5 mm or more in buccal alveolar wall followed by alveolar bone regeneration ABR and placement of an endosteal implant will be enrolled into the study
After exodontia participants will be randomized and divided into two groups in Experimental Group the socket will be grafted with rhBMP-2-BBM granules 10-025 mm in Control Group the sockets will be grafted with Bio-Oss granules 10-025 mm and covered with porcine collagen barrier membrane Bio-Gide
The end of the study will be fixed at the implantation surgery seventeen 17 weeks after exodontia an ABR Cone beam computed tomography CBCT scans will be made immediately after 0 and sixteen 16 weeks after exodontia an ABR and the gain in alveolar bone height will be estimated and used as the primary outcome for comparison of both groups
As secondary efficacy outcomes the change in alveolar bone width estimated from the CBCT scans initial 0 and at seventeenth 17th week after tooth extraction the change in dental arch dimensions estimated from tridimensional models obtained from intraoral scans at one week before -1 and sixteen 16 weeks exodontia an ABR and the amounts of new bone remnant material and connective tissue histomorphometrically measured in a bone biopsy collected during the implantation surgery at seventeenth 17th week will be considered
Healing of gingival tissues at first 1st and second 2nd week and incidence of adverse reactions at first 1st second 2nd and sixteenth 16th week are used as secondary safety outcomes
Detailed Description:
It is an interventional and therapeutic clinical trial as well as unicentric prospective parallel controlled random and doble-blind participants and outcomes assessors
It is aimed to assess the efficacy and safety of an experimental combined medical device consisting of rhBMP-2-loaded bovine bone mineral rhBMP-2-BBM granules 10-025 mm for alveolar bone regeneration ABR after extraction of a hopeless tooth incisor canine or premolar both in upper and lower arch maxilla having not less than 5 mm of bone height loss in vestibular wall and planned insertion of an endosteal dental implant and prosthetic rehabilitation
Participants will be recruited among patients attending the Dental Clinic of the Faculty of Dentistry of the Universidad Complutense de Madrid Spain There will be enrolled forty 40 voluntary both sex age 18 years and older requiring extraction of one 1 hopeless tooth incisor canine or premolar with loss of bone height of five 5 mm or more in vestibular alveolar wall followed by alveolar bone regeneration ABR and placement of an endosteal implant Participants will be randomly and equitably distributed in two groups Experimental and Control each counting 20 participants
Experimental group will be treated with rhBMP-2-BBM granules 10-025 mm and Control group with Bio-Oss granules 10-025 mmm and porcine collagen barrier membrane Bio-Gide
The enrollment will be open a maximum period of 12 months Treatment and follow-up will last 18 weeks between the enrollment of one participant and the end of the study
The research hypothesis is rhBMP-2-BBM is more effective than and as safe as Bio-OssBio-Gide for ABR of post-exodontia sockets with severe loss of vestibular bone height
Outcomes are
Primary Efficacy Outcome Bone height gain 16 weeks after baseline radiographically measured
Secondary Efficacy Outcomes
Bone width change 16 weeks after baseline radiographically measured
Dental arch dimensional change 16 weeks after baseline measured from digital models
Need for second bone augmentation 17 weeks after baseline clinically assessed
Amounts of New Bone Remnant Material and Connective Tissue 17 weeks after baseline histomorphometrically measured
Secondary Safety Outcomes
Early Healing Index 1 and 2 weeks after baseline clinically assessed
Adverse reactions 1 2 and 16 weeks after baseline clinically assessed Enrollment Potential participants will be asked and examined to check they fulfil the inclusion criteria and vestibular bone height of the affected tooth will be measured by probing Those fulfilling inclusion criteria will receive detailed explanation on the characteristics of the trial their rights as participant and asked for their consent to participate Those accepting will receive a copy of the informed consent form and will be scheduled for a First Visit
First Visit 1 week before baseline Participants will be asked to confirm full comprehension of their rights and duties and their will to participate and required to provide the signed informed consent form A digital scan of affected area including hopeless tooth and it neighbors will be obtained The resulting STL file will be used to obtain the base dimensional measure of the alveolar ridge The base STL file will be also used to design a customized splint which will be manufactured in thermoplastic polymer by 3D-printing and used in all CBCT scans to standardize radiographic measurements of height and width of the alveolar bone The Second Visit will be scheduled in the term of 1 week 1 day and participant will be indicated to brush teeth thrice a day and to rinse mouth with 012 chlorhexidine twice a day till the appointment day and amoxicillin 750 mg8 h or clindamycin 300 mg6 h for 24 h before the appointment day
Second Visit baseline Atraumatic exodontia will be carried out under local anesthesia using a syndesmotome manual or coupled to a piezosurgery unit avoiding to damage the alveolar bone walls The vestibular bone height will be probed to confirm the loss is greater than 5 mm If not the patient will be excluded and will continue to be treated by conventional procedures Socket will be thoroughly curetted and CBCT scan with the customized splint will be obtained before the ABR treatment Treatment with rhBMP-2-BBM or Bio-OssBio-Gide will be randomly assigned and ABR procedure will be performed
The socket is to be filled to the height of the interdental bone tables with the granules and gingiva is sutured with cross mattress stitches For control group the granules of Bio-Oss will be covered with the Bio-Gide membrane before suturing
The Third Visit will be scheduled in the term of 1 week 2 days and amoxicillin 750 mg8 h or clindamycin 300 mg6h horas during the next 8 days is to be indicated acetaminophen 1 g8 h in case of pain and ibuprofen 400 mg8 h in case of swelling till remission of symptoms Oral care for the next two 2 weeks will consist in normal teeth brushing excluding the affected area mouth rinsing with 012 chlorhexidine twice a day and avoiding use any removable prosthesis affecting regenerated area A phone number will be provided to report any persistent 4-5 days adverse effect or emergency
Third Visit 1 week after baseline Healing and adverse reactions outcomes will be assessed The Early Healing Index PMID 12795787 will be used for healing assessment Adverse reactions are to be assessed on the basis of clinical exam and participant questioning Reactions to consider are facial erythema local edema local erythema fever local pain granules exfoliation and suppuration and will be qualified as none mild moderate or severe A unique blind outcome assessor previously trained will assess both outcomes Stitches will be removed and the Fourth Visit scheduled in a term of 2 weeks 2 days from baseline
Fourth Visit 2 weeks after baseline Assessment of healing and adverse reactions outcomes will be performed as above and the Fifth Visit will be scheduled in a term of 16 weeks 1 week after baseline
Fifth Visit 16 weeks after baseline
Clinical exam and assessment of adverse reactions outcome will be performed Digital and CBCT using the customized splint scans will be obtained and used to assess the outcomes of bone height gain and bone width change according to PMID 30883942 and dental arch dimensional change as stated by PMID 30508313 by trained and calibrated blind assessor The Sixth Visit will be scheduled in the term of 17 weeks 1 week and participant will be indicated as in the first visit
Sixth Visit 17 weeks after baseline End of Study A buccal full thickness flap will be elevated and dimensions and quality of the alveolar bone ridge will be inspected to assess the need for second bone augmentation outcome If second bone augmentation is needed participant goes out the trial receive the bone augmentation and continues conventional treatment
If no need for second bone augmentation a biopsy specimen of the alveolar regenerated bone will be harvested exactly in the area where dental implant will be placed At this point participant exit the study and goes on to conventional endosteal implantation and subsequent prosthetic rehabilitation
The biopsy specimen is fixed in 10 buffered formalin and kept at 4 ºC until processing for histology and histomorphometry studies PMID 6809919 The amounts of New Bone Remnant Material and Connective Tissue 17 weeks after baseline will be assessed by a trained and calibrated blind assessor as indicated in PMID 28634845
It is aimed to assess the efficacy and safety of an experimental combined medical device consisting of rhBMP-2-loaded bovine bone mineral rhBMP-2-BBM granules 10-025 mm for alveolar bone regeneration ABR after extraction of a hopeless tooth incisor canine or premolar both in upper and lower arch maxilla having not less than 5 mm of bone height loss in vestibular wall and planned insertion of an endosteal dental implant and prosthetic rehabilitation
Participants will be recruited among patients attending the Dental Clinic of the Faculty of Dentistry of the Universidad Complutense de Madrid Spain There will be enrolled forty 40 voluntary both sex age 18 years and older requiring extraction of one 1 hopeless tooth incisor canine or premolar with loss of bone height of five 5 mm or more in vestibular alveolar wall followed by alveolar bone regeneration ABR and placement of an endosteal implant Participants will be randomly and equitably distributed in two groups Experimental and Control each counting 20 participants
Experimental group will be treated with rhBMP-2-BBM granules 10-025 mm and Control group with Bio-Oss granules 10-025 mmm and porcine collagen barrier membrane Bio-Gide
The enrollment will be open a maximum period of 12 months Treatment and follow-up will last 18 weeks between the enrollment of one participant and the end of the study
The research hypothesis is rhBMP-2-BBM is more effective than and as safe as Bio-OssBio-Gide for ABR of post-exodontia sockets with severe loss of vestibular bone height
Outcomes are
Primary Efficacy Outcome Bone height gain 16 weeks after baseline radiographically measured
Secondary Efficacy Outcomes
Bone width change 16 weeks after baseline radiographically measured
Dental arch dimensional change 16 weeks after baseline measured from digital models
Need for second bone augmentation 17 weeks after baseline clinically assessed
Amounts of New Bone Remnant Material and Connective Tissue 17 weeks after baseline histomorphometrically measured
Secondary Safety Outcomes
Early Healing Index 1 and 2 weeks after baseline clinically assessed
Adverse reactions 1 2 and 16 weeks after baseline clinically assessed Enrollment Potential participants will be asked and examined to check they fulfil the inclusion criteria and vestibular bone height of the affected tooth will be measured by probing Those fulfilling inclusion criteria will receive detailed explanation on the characteristics of the trial their rights as participant and asked for their consent to participate Those accepting will receive a copy of the informed consent form and will be scheduled for a First Visit
First Visit 1 week before baseline Participants will be asked to confirm full comprehension of their rights and duties and their will to participate and required to provide the signed informed consent form A digital scan of affected area including hopeless tooth and it neighbors will be obtained The resulting STL file will be used to obtain the base dimensional measure of the alveolar ridge The base STL file will be also used to design a customized splint which will be manufactured in thermoplastic polymer by 3D-printing and used in all CBCT scans to standardize radiographic measurements of height and width of the alveolar bone The Second Visit will be scheduled in the term of 1 week 1 day and participant will be indicated to brush teeth thrice a day and to rinse mouth with 012 chlorhexidine twice a day till the appointment day and amoxicillin 750 mg8 h or clindamycin 300 mg6 h for 24 h before the appointment day
Second Visit baseline Atraumatic exodontia will be carried out under local anesthesia using a syndesmotome manual or coupled to a piezosurgery unit avoiding to damage the alveolar bone walls The vestibular bone height will be probed to confirm the loss is greater than 5 mm If not the patient will be excluded and will continue to be treated by conventional procedures Socket will be thoroughly curetted and CBCT scan with the customized splint will be obtained before the ABR treatment Treatment with rhBMP-2-BBM or Bio-OssBio-Gide will be randomly assigned and ABR procedure will be performed
The socket is to be filled to the height of the interdental bone tables with the granules and gingiva is sutured with cross mattress stitches For control group the granules of Bio-Oss will be covered with the Bio-Gide membrane before suturing
The Third Visit will be scheduled in the term of 1 week 2 days and amoxicillin 750 mg8 h or clindamycin 300 mg6h horas during the next 8 days is to be indicated acetaminophen 1 g8 h in case of pain and ibuprofen 400 mg8 h in case of swelling till remission of symptoms Oral care for the next two 2 weeks will consist in normal teeth brushing excluding the affected area mouth rinsing with 012 chlorhexidine twice a day and avoiding use any removable prosthesis affecting regenerated area A phone number will be provided to report any persistent 4-5 days adverse effect or emergency
Third Visit 1 week after baseline Healing and adverse reactions outcomes will be assessed The Early Healing Index PMID 12795787 will be used for healing assessment Adverse reactions are to be assessed on the basis of clinical exam and participant questioning Reactions to consider are facial erythema local edema local erythema fever local pain granules exfoliation and suppuration and will be qualified as none mild moderate or severe A unique blind outcome assessor previously trained will assess both outcomes Stitches will be removed and the Fourth Visit scheduled in a term of 2 weeks 2 days from baseline
Fourth Visit 2 weeks after baseline Assessment of healing and adverse reactions outcomes will be performed as above and the Fifth Visit will be scheduled in a term of 16 weeks 1 week after baseline
Fifth Visit 16 weeks after baseline
Clinical exam and assessment of adverse reactions outcome will be performed Digital and CBCT using the customized splint scans will be obtained and used to assess the outcomes of bone height gain and bone width change according to PMID 30883942 and dental arch dimensional change as stated by PMID 30508313 by trained and calibrated blind assessor The Sixth Visit will be scheduled in the term of 17 weeks 1 week and participant will be indicated as in the first visit
Sixth Visit 17 weeks after baseline End of Study A buccal full thickness flap will be elevated and dimensions and quality of the alveolar bone ridge will be inspected to assess the need for second bone augmentation outcome If second bone augmentation is needed participant goes out the trial receive the bone augmentation and continues conventional treatment
If no need for second bone augmentation a biopsy specimen of the alveolar regenerated bone will be harvested exactly in the area where dental implant will be placed At this point participant exit the study and goes on to conventional endosteal implantation and subsequent prosthetic rehabilitation
The biopsy specimen is fixed in 10 buffered formalin and kept at 4 ºC until processing for histology and histomorphometry studies PMID 6809919 The amounts of New Bone Remnant Material and Connective Tissue 17 weeks after baseline will be assessed by a trained and calibrated blind assessor as indicated in PMID 28634845
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIV-ES-22-09-040949 | OTHER | European Data Base on Medical Devices EUDAMED2 | None |
| 89421EC-R | OTHER | None | None |