Study Summary
This trial will compare two types of materials used in socket preservation procedures after four months.
Eligible Conditions
- Alveolar Bone Loss
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
3 Primary · 1 Secondary · Reporting Duration: 4 months
4 months
Alveolar ridge height
Alveolar ridge width
Buccal soft tissue thickness
Percentage of vital bone present
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
calcium phosphosilicate putty alloplast graft
1 of 2
demineralized and mineralized combination putty bone allograft
1 of 2
Active Control
Experimental Treatment
30 Total Participants · 2 Treatment Groups
Primary Treatment: demineralized and mineralized combination putty bone allograft · No Placebo Group · Phase 4
demineralized and mineralized combination putty bone allograft
Biological
Experimental Group · 1 Intervention: demineralized and mineralized combination putty bone allograft · Intervention Types: Biologicalcalcium phosphosilicate putty alloplast graft
Biological
ActiveComparator Group · 1 Intervention: calcium phosphosilicate putty alloplast graft · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months
Who is running the clinical trial?
BioHorizons, Inc.Industry Sponsor
15 Previous Clinical Trials
513 Total Patients Enrolled
1 Trials studying Alveolar Bone Loss
25 Patients Enrolled for Alveolar Bone Loss
University of LouisvilleLead Sponsor
314 Previous Clinical Trials
72,910 Total Patients Enrolled
1 Trials studying Alveolar Bone Loss
15 Patients Enrolled for Alveolar Bone Loss
Bindu Dukka, BDS,MSD,MPHPrincipal InvestigatorDirector, Graduate Periodontics, University of Louisville
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have one non-molar tooth requiring extraction that will be replaced by a dental implant.
You are a healthy male or female.\n
References
- Araujo, Mauricio G., and Jan Lindhe. 2005. “Dimensional Ridge Alterations Following Tooth Extraction. An Experimental Study in the Dog”. Journal of Clinical Periodontology. Wiley. doi:10.1111/j.1600-051x.2005.00642.x.
- Araújo, Mauricio G., João Carlos Costa da Silva, Arthur Furtado de Mendonça, and Jan Lindhe. 2014. “Ridge Alterations Following Grafting of Fresh Extraction Sockets in Man. A Randomized Clinical Trial”. Clinical Oral Implants Research. Wiley. doi:10.1111/clr.12366.
- O'Leary, Timothy J., Robert B. Drake, and James E. Naylor. 1972. “The Plaque Control Record”. Journal of Periodontology. Wiley. doi:10.1902/jop.1972.43.1.38.
- Laster, Larry, Kenneth W. Laudenbach, and Norman H. Stoller. 1975. “An Evaluation of Clinical Tooth Mobility Measurements”. Journal of Periodontology. Wiley. doi:10.1902/jop.1975.46.10.603.
- Jung, Ronald E., Alexander Philipp, Beat M. Annen, Luca Signorelli, Daniel S. Thoma, Christoph H.F. Hämmerle, Thomas Attin, and Patrick Schmidlin. 2012. “Radiographic Evaluation of Different Techniques for Ridge Preservation After Tooth Extraction: A Randomized Controlled Clinical Trial”. Journal of Clinical Periodontology. Wiley. doi:10.1111/jcpe.12027.
- Barone, Antonio, Massimiliano Ricci, Paolo Tonelli, Stefano Santini, and Ugo Covani. 2012. “Tissue Changes of Extraction Sockets in Humans: A Comparison of Spontaneous Healing Vs. Ridge Preservation with Secondary Soft Tissue Healing”. Clinical Oral Implants Research. Wiley. doi:10.1111/j.1600-0501.2012.02535.x.
- Leblebicioglu, Binnaz, Mabel Salas, Yirae Ort, Ashley Johnson, Vedat O. Yildiz, Do-Gyoon Kim, Sudha Agarwal, and Dimitris N. Tatakis. 2013. “Determinants of Alveolar Ridge Preservation Differ by Anatomic Location”. Journal of Clinical Periodontology. Wiley. doi:10.1111/jcpe.12065.
- Llanos, Alexandre Hugo, Vítor Marques Sapata, Ronald E. Jung, Christoph H. Hämmerle, Daniel S. Thoma, João Batista César Neto, Claudio Mendes Pannuti, and Giuseppe Alexandre Romito. 2019. “Comparison Between Two Bone Substitutes for Alveolar Ridge Preservation After Tooth Extraction: Cone‐beam Computed Tomography Results of a Non‐inferiority Randomized Controlled Trial”. Journal of Clinical Periodontology. Wiley. doi:10.1111/jcpe.13079.
- Asaad, Nour, and Mohannad Laflouf. 2022. “Effectiveness of Apple Cider Vinegar and Mechanical Removal on Dental Plaque and Gingival Inflammation of Children with Cerebral Palsy”. Cureus. Cureus, Inc.. doi:10.7759/cureus.26874.
- Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
- Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.
- Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12.
- Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Llanos AH, Sapata VM, Jung RE, Hammerle CH, Thoma DS, Cesar Neto JB, Pannuti CM, Romito GA. Comparison between two bone substitutes for alveolar ridge preservation after tooth extraction: Cone-beam computed tomography results of a non-inferiority randomized controlled trial. J Clin Periodontol. 2019 Mar;46(3):373-381. doi: 10.1111/jcpe.13079. Epub 2019 Mar 3.
- O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
- Laster L, Laudenbach KW, Stoller NH. An evaluation of clinical tooth mobility measurements. J Periodontol. 1975 Oct;46(10):603-7. doi: 10.1902/jop.1975.46.10.603.
- Himabindu Dukka 2022. "Alveolar Ridge Preservation With Putty Allograft vs. Putty Alloplast Graft". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05484492.
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