NCT03573193

Brief Summary

Inadequate ridge width to allow implant placement, it noted that when extraction takes place and ridge preservation is not utilized the site of extraction could lose 40% to 60% of bone height and width within 2 to 3 years and subsequent loss of 0.25% to 0.5% annually. it reported as much as 4 mm loss of ridge width in extraction alone sites within 6 months. Using an atraumatic tooth extraction technique preserves osseous walls thereby improving the chances of osseous graft success. The goal of ridge preservation is minimizing bone loss to preserve the maximum final, healed ridge dimensions. Socket preservation is done using a hard tissue graft like xenograft bone or synthetic bone substitutes and prevent hazard of surgical intervention which needed during implant loading due to bone resorption.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

June 13, 2018

Last Update Submit

June 28, 2018

Conditions

Keywords

xenograft bonesynthetic bone substitutes

Outcome Measures

Primary Outcomes (1)

  • Prevent post extraction ridge volume loss and decrease bone resorption detected by CBCT to prepare for success implant loading

    socket preservation is minimizing bone loss to preserve the maximum final, healed ridge dimensions

    base lline

Study Arms (2)

study group:

ACTIVE COMPARATOR

ridge preservation alveolar ridge socket preserved using alloplastic material beta tri calcium phosphate type

Other: ridge preservation

control group

OTHER

ridge preservation (alveolar ridge socket preserved using xenograft material Bio-oss type

Other: ridge preservation

Interventions

Intra operative procedures (for both groups) ridge preservation * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * A crestal incision was made, and a mucoperiosteal flap was elevated. Implant osteotomies were prepared according to the recommendations and desired dimensions of implants. * In study group: tooth extraction with ridge preservation using deproteinized bovine bone mineral Bio-Oss * In the comparators group: tooth extraction with ridge preservation using an alloplastic ceramic material beta tricalcium phosphate (TCP).

control groupstudy group:

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Good oral hygiene.
  • Age from 25-60 years
  • Both sexes
  • Sufficient bone volume
  • Presence of non-restorable mandibular molars.

You may not qualify if:

  • Extreme bone atrophy.
  • Patients who have systemic disorders that might interfere with bone metabolism.
  • Pregnant patients.
  • Bad oral hygiene.
  • Patients with bone diseases.
  • Patient with limited mouth opening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (33)

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  • Artzi Z, Nemcovsky CE. The application of deproteinized bovine bone mineral for ridge preservation prior to implantation. Clinical and histological observations in a case report. J Periodontol. 1998 Sep;69(9):1062-7. doi: 10.1902/jop.1998.69.9.1062.

  • Christensen GJ. Ridge preservation: why not? J Am Dent Assoc. 1996 May;127(5):669-70. doi: 10.14219/jada.archive.1996.0279.

  • Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.

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  • Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.

  • De Buitrago JG, Avila-Ortiz G, Elangovan S. Quality assessment of systematic reviews on alveolar ridge preservation. J Am Dent Assoc. 2013 Dec;144(12):1349-57. doi: 10.14219/jada.archive.2013.0070.

  • Omran M, Min S, Abdelhamid A, Liu Y, Zadeh HH. Alveolar ridge dimensional changes following ridge preservation procedure: part-2 - CBCT 3D analysis in non-human primate model. Clin Oral Implants Res. 2016 Jul;27(7):859-66. doi: 10.1111/clr.12701. Epub 2015 Oct 25.

  • Barone A, Orlando B, Cingano L, Marconcini S, Derchi G, Covani U. A randomized clinical trial to evaluate and compare implants placed in augmented versus non-augmented extraction sockets: 3-year results. J Periodontol. 2012 Jul;83(7):836-46. doi: 10.1902/jop.2011.110205. Epub 2011 Dec 5.

  • Rasperini G, Canullo L, Dellavia C, Pellegrini G, Simion M. Socket grafting in the posterior maxilla reduces the need for sinus augmentation. Int J Periodontics Restorative Dent. 2010 Jun;30(3):265-73.

  • Darby I, Chen S, De Poi R. Ridge preservation: what is it and when should it be considered. Aust Dent J. 2008 Mar;53(1):11-21. doi: 10.1111/j.1834-7819.2007.00008.x.

  • Nazirkar G, Singh S, Dole V, Nikam A. Effortless effort in bone regeneration: a review. J Int Oral Health. 2014 Jun;6(3):120-4. Epub 2014 Jun 26.

  • Zaner DJ, Yukna RA. Particle size of periodontal bone grafting materials. J Periodontol. 1984 Jul;55(7):406-9. doi: 10.1902/jop.1984.55.7.406.

  • Callan DP, Rohrer MD. Use of bovine-derived hydroxyapatite in the treatment of edentulous ridge defects: a human clinical and histologic case report. J Periodontol. 1993 Jun;64(6):575-82. doi: 10.1902/jop.1993.64.6.575.

  • Esposito M, Grusovin MG, Felice P, Karatzopoulos G, Worthington HV, Coulthard P. Interventions for replacing missing teeth: horizontal and vertical bone augmentation techniques for dental implant treatment. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD003607. doi: 10.1002/14651858.CD003607.pub4.

  • Cameron HU, Macnab I, Pilliar RM. Evaluation of biodegradable ceramic. J Biomed Mater Res. 1977 Mar;11(2):179-86. doi: 10.1002/jbm.820110204.

  • Jarcho M. Biomaterial aspects of calcium phosphates. Properties and applications. Dent Clin North Am. 1986 Jan;30(1):25-47.

  • LeGeros RZ. Properties of osteoconductive biomaterials: calcium phosphates. Clin Orthop Relat Res. 2002 Feb;(395):81-98. doi: 10.1097/00003086-200202000-00009.

  • Nilsson M, Fernandez E, Sarda S, Lidgren L, Planell JA. Characterization of a novel calcium phosphate/sulphate bone cement. J Biomed Mater Res. 2002 Sep 15;61(4):600-7. doi: 10.1002/jbm.10268.

  • Artzi Z, Weinreb M, Givol N, Rohrer MD, Nemcovsky CE, Prasad HS, Tal H. Biomaterial resorption rate and healing site morphology of inorganic bovine bone and beta-tricalcium phosphate in the canine: a 24-month longitudinal histologic study and morphometric analysis. Int J Oral Maxillofac Implants. 2004 May-Jun;19(3):357-68.

  • Kotani S, Fujita Y, Kitsugi T, Nakamura T, Yamamuro T, Ohtsuki C, Kokubo T. Bone bonding mechanism of beta-tricalcium phosphate. J Biomed Mater Res. 1991 Oct;25(10):1303-15. doi: 10.1002/jbm.820251010.

  • Evans RW, Cheung HS, McCarty DJ. Cultured human monocytes and fibroblasts solubilize calcium phosphate crystals. Calcif Tissue Int. 1984 Dec;36(6):645-50. doi: 10.1007/BF02405384.

  • Owens JL, Cheung HS, McCarty DJ. Endocytosis precedes dissolution of basic calcium phosphate crystals by murine macrophages. Calcif Tissue Int. 1986 Mar;38(3):170-4. doi: 10.1007/BF02556877.

  • Gregoire M, Orly I, Menanteau J. The influence of calcium phosphate biomaterials on human bone cell activities. An in vitro approach. J Biomed Mater Res. 1990 Feb;24(2):165-77. doi: 10.1002/jbm.820240204.

  • Gaasbeek RD, Toonen HG, van Heerwaarden RJ, Buma P. Mechanism of bone incorporation of beta-TCP bone substitute in open wedge tibial osteotomy in patients. Biomaterials. 2005 Nov;26(33):6713-9. doi: 10.1016/j.biomaterials.2005.04.056.

  • Fujita R, Yokoyama A, Nodasaka Y, Kohgo T, Kawasaki T. Ultrastructure of ceramic-bone interface using hydroxyapatite and beta-tricalcium phosphate ceramics and replacement mechanism of beta-tricalcium phosphate in bone. Tissue Cell. 2003 Dec;35(6):427-40. doi: 10.1016/s0040-8166(03)00067-3.

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  • Rey C. Calcium phosphate biomaterials and bone mineral. Differences in composition, structures and properties. Biomaterials. 1990 Jul;11:13-5.

  • Trisi P, Rao W, Rebaudi A, Fiore P. Histologic effect of pure-phase beta-tricalcium phosphate on bone regeneration in human artificial jawbone defects. Int J Periodontics Restorative Dent. 2003 Feb;23(1):69-77.

Study Officials

  • AMR A al azim, professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

wahid Y al hussiney, B.D.S

CONTACT

mohammed A abd rassoul, p.h.d

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Blinded participants
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized clinical trial. • Unicenter, single blinded, with equal randomization, active controlled, parallel group study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2018

First Posted

June 29, 2018

Study Start

July 1, 2018

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share