Alveolar Bone Loss Clinical Trial
— PROTEOGRAFTOfficial 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)
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 (1.0-0.25 mm); in Control Group the sockets will be grafted with Bio-Oss granules (1.0-0.25 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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 15, 2024 |
Est. primary completion date | September 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Healthy patients with one tooth to be extracted, from incisor to premolar, and with buccal bone wall loss of 5 mm or more - Plaque index lower than 30% - Eighteen (18) years old and elder. - Willing to participate and written informed consent Exclusion Criteria: - Heavy smokers (more than 20 cigarettes per day) - Plaque index greater than 30 % - Pathologies hindering interventions or influencing healing or host response - Inability to comply scheduled follow-up - Comprehension disability that compromises informed consent and compliance with medical instructions - Receptor of any other experimental treatments, actual or in past 30 days - Current pregnant patients or planning to get pregnant in short term - Breastfeeding mothers |
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Dentistry, Universidad Complutense de Madrid | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid | NORICUM SL |
Spain,
Donath K, Breuner G. A method for the study of undecalcified bones and teeth with attached soft tissues. The Sage-Schliff (sawing and grinding) technique. J Oral Pathol. 1982 Aug;11(4):318-26. doi: 10.1111/j.1600-0714.1982.tb00172.x. — View Citation
Jo DW, Cho YD, Seol YJ, Lee YM, Lee HJ, Kim YK. A randomized controlled clinical trial evaluating efficacy and adverse events of different types of recombinant human bone morphogenetic protein-2 delivery systems for alveolar ridge preservation. Clin Oral Implants Res. 2019 May;30(5):396-409. doi: 10.1111/clr.13423. Epub 2019 Apr 11. — View Citation
Ortiz-Vigon A, Martinez-Villa S, Suarez I, Vignoletti F, Sanz M. Histomorphometric and immunohistochemical evaluation of collagen containing xenogeneic bone blocks used for lateral bone augmentation in staged implant placement. Int J Implant Dent. 2017 Dec;3(1):24. doi: 10.1186/s40729-017-0087-1. Epub 2017 Jun 21. — View Citation
Sanz-Martin I, Encalada C, Sanz-Sanchez I, Aracil J, Sanz M. Soft tissue augmentation at immediate implants using a novel xenogeneic collagen matrix in conjunction with immediate provisional restorations: A prospective case series. Clin Implant Dent Relat Res. 2019 Feb;21(1):145-153. doi: 10.1111/cid.12696. Epub 2018 Dec 3. — View Citation
Wachtel H, Schenk G, Bohm S, Weng D, Zuhr O, Hurzeler MB. Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. J Clin Periodontol. 2003 Jun;30(6):496-504. doi: 10.1034/j.1600-051x.2003.00013.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone height gain after tooth extraction and socket regeneration | Difference between alveolar bone heights measured immediately after tooth extraction and 16 weeks after. Bone heights are measured from the CBCT scans obtained in the second and fifth visits using as reference a customized splint as elsewhere (PMID: 30883942) | 16 weeks | |
Secondary | Bone width changes after tooth extraction and socket regeneration | Difference between alveolar bone widths measured immediately after tooth extraction and 16 weeks after. Bone widths are measured at 25%, 50% and 75% of bone height from the CBCT scans obtained in the second and fifth visits using as reference a customized splint as elsewhere (PMID: 30883942) | 16 weeks | |
Secondary | Dental arch dimensional changes after tooth extraction and socket regeneration | Differences between volumes and widths of the dental arch region affected measured 1 week before and 16 weeks after tooth extraction. Arch widths are measured at distances of 1, 2, 3, 4 and 5 mm from gingival margin. Digital models of the affected area obtained from the intraoral scans obtained in the first and fifth visits are used for measures as elsewhere (PMID: 30508313) | 16 weeks | |
Secondary | Need for second bone augmentation after tooth extraction and socket regeneration | The outcome will be intraoperatively assessed at the surgery of Sixth Visit after rising buccal full thickness flap and exposing the regenerated area. The outcome assessor will exam the regenerated socket and will decide if the quality and volume of bone is enough to continue to the insertion of a endosteal implant (NO); or further bone augmentation is needed (YES) | 17 weeks | |
Secondary | Amounts of New Bone; Remnant Material and Connective Tissue after tooth extraction and socket regeneration | At the surgery of the Sixth Visit a biopsy of the alveolar regenerated bone will be harvested exactly in the place where endosteal implant is to be inserted, with the aid of a trephine bur. The bur with the specimen is fixed in formalin, dehydrated and resin embedded. Longitudinal sections will be cut and polished and dyed with Levai-Laczkó stain (PMID: 68009919) and the percentages of New Bone; Remnant Material and Connective Tissue will be histomorphometrically measured as elsewhere (PMID: 28634845) | 17 weeks | |
Secondary | Early Healing Index after tooth extraction and socket regeneration | At the clinical exam in Third and Fourth Visits the outcome assessor will qualify the Early Healing Index using a scale of 1 to 5 as elsewhere (PMID: 12795787) | 1 and 2 weeks | |
Secondary | Adverse reactions after tooth extraction and socket regeneration | Adverse reactions will be assessed on the basis of clinical exam and participant questioning practiced by the outcome assessor at Third, Fourth and Fifth Visits. Reactions to consider are: facial erythema, local edema, local erythema, fever, local pain, granules exfoliation, and suppuration; and they will be qualified as none, mild, moderate, or severe. Any other reaction observed will be registered and qualified with the same scale. | 1, 2 and 16 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05470673 -
Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation
|
N/A | |
Recruiting |
NCT02580721 -
The Influence of Mucosal Tissue Thickness on Soft and Hard Tissue Changes Around Implants
|
N/A | |
Completed |
NCT02515058 -
Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
|
N/A | |
Enrolling by invitation |
NCT02209311 -
Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs
|
Phase 1/Phase 2 | |
Completed |
NCT02602223 -
Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures
|
Phase 2 | |
Completed |
NCT02255149 -
A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw
|
N/A | |
Recruiting |
NCT06081296 -
Dimensional Changes in Alveolar Ridge Preservation
|
N/A | |
Recruiting |
NCT05674331 -
Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation
|
N/A | |
Completed |
NCT03944811 -
Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Piezoelectric Surgery Versus The Conventional Osteotome Technique
|
N/A | |
Completed |
NCT03045458 -
Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures
|
N/A | |
Completed |
NCT05595746 -
Radiological Bone Loss on Different Levels of Dental Implants
|
N/A | |
Completed |
NCT03357705 -
Effectiveness in Limiting the Need to Elevate the Maxillary Sinus
|
N/A | |
Recruiting |
NCT05311735 -
Mineralized and Partial Demineralized Dentin Graft Compared to FDBA
|
N/A | |
Completed |
NCT05494476 -
Stability of the Marginal Bone Around Subcrestal Implants
|
N/A | |
Not yet recruiting |
NCT05536479 -
Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation
|
N/A | |
Active, not recruiting |
NCT02275767 -
Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
|
N/A | |
Active, not recruiting |
NCT02120053 -
Interest of Bone Substitute Material in Immediate Complete Denture
|
Phase 2/Phase 3 | |
Completed |
NCT01728844 -
GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
|
N/A | |
Terminated |
NCT00991432 -
Localized Alveolar Ridge Augmentation With Space Maintenance Devices
|
N/A | |
Terminated |
NCT00991965 -
Localized Alveolar Ridge Augmentation With Dental Implant
|
N/A |