NCT04022538

Brief Summary

Vertical bone height has always presented challenge for the clinicians especially in the anterior aesthetic zone. Therefore, this trial will attempt to compare whether better vertical bone height and implant placement technique can be achieved using simultaneous implant placement with the sandwich osteotomy, which is a time saving procedure performed in a single stage surgery; when compared to using fixation plates to support the segment followed by delayed implant placement.

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 2019

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

Study Start

First participant enrolled

July 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 15, 2019

Last Update Submit

July 16, 2019

Conditions

Alveolar Bone Resorption

Keywords

Vertical bone augmentationInlay bone graftDental ImplantsSandwich Osteotomy

Outcome Measures

Primary Outcomes (1)

  • Final Vertical Alveolar ridge height

    Measured in millimeters from the crest of the alveolar ridge to the floor of nasal cavity using cone-beam computed tomography

    4 months postoperatively

Secondary Outcomes (1)

  • Patient Satisfaction: scale from 1 to 10

    4 months postoperatively

Study Arms (2)

Sandwich osteotomy with simultaneous implant placement

EXPERIMENTAL

This group will undergo Sandwich osteotomy procedure and segment will be fixed using the dental implants placed simultaneously during the same surgical procedure. The remaining gap will be filled using xenograft.

Procedure: Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement

Sandwich osteotomy using micro-plates fixation

ACTIVE COMPARATOR

This group will undergo Sandwich osteotomy procedure and segment will be fixed using micro-plates and screws, and the gap will be filled using xenograft.

Procedure: Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation

Interventions

Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placementPROCEDURE

Following the Sandwich Osteotomy procedure described in the study description, the following steps will be done: * The first implant osteotomy will be prepared and placed while a chisel is placed between the down fractured segment and the basal bone, and then the second implant will be installed. * The gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute. * Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material.

Also known as: Inlay alveolar bone grafting with simultaneous implant placement
Sandwich osteotomy with simultaneous implant placement
Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixationPROCEDURE

Following the Sandwich Osteotomy procedure described in the study description, the following steps will be done: * The created gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute. * The mobilized segment is to be fixed to the basal bone using micro-plates and micro-screws. * Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material.

Sandwich osteotomy using micro-plates fixation

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range from 20-55 years. No sex predilection.
  • Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
  • Edentulous anterior maxilla with vertically deficient alveolar ridge that is less than 10 mm measured from the crest of the alveolar ridge to the nasal floor.
  • Normal vertical dimension with increased inter-arch space.
  • The minimum number of missing teeth in the anterior maxillary alveolar ridge is two adjacent anterior teeth.

You may not qualify if:

  • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
  • Previous grafting procedures in the edentulous area.
  • Deficient horizontal dimensions of the alveolar ridge i.e. width is less than 5 mm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (23)

  • Bashutski JD, Wang HL. Common implant esthetic complications. Implant Dent. 2007 Dec;16(4):340-8. doi: 10.1097/ID.0b013e318159ca05.

    PMID: 18091161BACKGROUND

  • Carlsson GE, Bergman B, Hedegard B. Changes in contour of the maxillary alveolar process under immediate dentures. A longitudinal clinical and x-ray cephalometric study covering 5 years. Acta Odontol Scand. 1967 Jun;25(1):45-75. doi: 10.3109/00016356709072522. No abstract available.

    PMID: 5233859BACKGROUND

  • El Hadidy MS, Mounir M, Abou-Elfetouh A, Barakat A. Assessment of vertical ridge augmentation and labial prominence using buccal versus palatal approaches for maxillary segmental sandwich osteotomy (inlay technique): A randomized clinical trial. Clin Implant Dent Relat Res. 2018 Oct;20(5):722-728. doi: 10.1111/cid.12653. Epub 2018 Jul 18.

    PMID: 30019829BACKGROUND

  • Esposito M, Grusovin MG, Kwan S, Worthington HV, Coulthard P. Interventions for replacing missing teeth: bone augmentation techniques for dental implant treatment. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD003607. doi: 10.1002/14651858.CD003607.pub3.

    PMID: 18646092BACKGROUND

  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PMID: 17695343BACKGROUND

  • Jensen OT, Kuhlke L, Bedard JF, White D. Alveolar segmental sandwich osteotomy for anterior maxillary vertical augmentation prior to implant placement. J Oral Maxillofac Surg. 2006 Feb;64(2):290-6. doi: 10.1016/j.joms.2005.10.021.

    PMID: 16413903BACKGROUND

  • Kahnberg KE, Nystrom E, Bartholdsson L. Combined use of bone grafts and Branemark fixtures in the treatment of severely resorbed maxillae. Int J Oral Maxillofac Implants. 1989 Winter;4(4):297-304.

    PMID: 2639859BACKGROUND

  • Keestra JA, Barry O, Jong Ld, Wahl G. Long-term effects of vertical bone augmentation: a systematic review. J Appl Oral Sci. 2016 Jan-Feb;24(1):3-17. doi: 10.1590/1678-775720150357.

    PMID: 27008252BACKGROUND

  • Laviv A, Jensen OT, Tarazi E, Casap N. Alveolar sandwich osteotomy in resorbed alveolar ridge for dental implants: a 4-year prospective study. J Oral Maxillofac Surg. 2014 Feb;72(2):292-303. doi: 10.1016/j.joms.2013.09.036. Epub 2013 Oct 5.

    PMID: 24321312BACKGROUND

  • Lim G, Lin GH, Monje A, Chan HL, Wang HL. Wound Healing Complications Following Guided Bone Regeneration for Ridge Augmentation: A Systematic Review and Meta-Analysis. Int J Oral Maxillofac Implants. 2018 January/February;33(1):41-50. doi: 10.11607/jomi.5581. Epub 2017 Sep 22.

    PMID: 28938030BACKGROUND

  • Mansour HH, Badr A, Osman AH, Atef M. Anterior maxillary sandwich osteotomy technique with simultaneous implant placement: A novel approach for management of vertical deficiency. Clin Implant Dent Relat Res. 2019 Feb;21(1):160-168. doi: 10.1111/cid.12687. Epub 2018 Nov 9.

    PMID: 30411842BACKGROUND

  • Milinkovic I, Cordaro L. Are there specific indications for the different alveolar bone augmentation procedures for implant placement? A systematic review. Int J Oral Maxillofac Surg. 2014 May;43(5):606-25. doi: 10.1016/j.ijom.2013.12.004. Epub 2014 Jan 19.

    PMID: 24451333BACKGROUND

  • Mounir M, Mounir S, Abou-Elfetouh A, Shaker MA. Assessment of vertical ridge augmentation in anterior aesthetic zone using onlay xenografts with titanium mesh versus the inlay bone grafting technique: A randomized clinical trial. Int J Oral Maxillofac Surg. 2017 Nov;46(11):1458-1465. doi: 10.1016/j.ijom.2017.04.021. Epub 2017 May 16.

    PMID: 28526551BACKGROUND

  • Nkenke E, Neukam FW. Autogenous bone harvesting and grafting in advanced jaw resorption: morbidity, resorption and implant survival. Eur J Oral Implantol. 2014 Summer;7 Suppl 2:S203-17.

    PMID: 24977256BACKGROUND

  • Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. J Prosthet Dent. 1967 Jan;17(1):21-7. doi: 10.1016/0022-3913(67)90046-7. No abstract available.

    PMID: 5224784BACKGROUND

  • Politi M, Robiony M. Localized alveolar sandwich osteotomy for vertical augmentation of the anterior maxilla. J Oral Maxillofac Surg. 1999 Nov;57(11):1380-2. doi: 10.1016/s0278-2391(99)90883-2. No abstract available.

    PMID: 10555808BACKGROUND

  • Rachmiel A, Shilo D, Aizenbud D, Emodi O. Vertical Alveolar Distraction Osteogenesis of the Atrophic Posterior Mandible Before Dental Implant Insertion. J Oral Maxillofac Surg. 2017 Jun;75(6):1164-1175. doi: 10.1016/j.joms.2017.01.013. Epub 2017 Jan 21.

    PMID: 28208057BACKGROUND

  • Raghoebar GM, Meijndert L, Kalk WW, Vissink A. Morbidity of mandibular bone harvesting: a comparative study. Int J Oral Maxillofac Implants. 2007 May-Jun;22(3):359-65.

    PMID: 17622001BACKGROUND

  • Sakkas A, Wilde F, Heufelder M, Winter K, Schramm A. Autogenous bone grafts in oral implantology-is it still a "gold standard"? A consecutive review of 279 patients with 456 clinical procedures. Int J Implant Dent. 2017 Dec;3(1):23. doi: 10.1186/s40729-017-0084-4. Epub 2017 Jun 1.

    PMID: 28573552BACKGROUND

  • Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

    PMID: 12956475BACKGROUND

  • Tolstunov L. Classification of the alveolar ridge width: implant-driven treatment considerations for the horizontally deficient alveolar ridges. J Oral Implantol. 2014 Jul;40 Spec No:365-70. doi: 10.1563/aaid-joi-D-14-00023. Epub 2014 Feb 27.

    PMID: 24575743BACKGROUND

  • Rutkowski JL. Vertical Alveolar Ridge Augmentation in Implant Dentistry: A Surgical Manual and Horizontal Alveolar Ridge Augmentation in Implant Dentistry: A Surgical Manual. Tolstunov L, ed. Hoboken, NJ: John Wiley & Sons, Inc. Hoboken, New Jersey. J Oral Implantol. 2016 Dec;42(6):518. doi: 10.1563/aaid-joi-D-Review.4206. No abstract available.

    PMID: 28002717BACKGROUND

  • Tolstunov L, Hamrick JFE, Broumand V, Shilo D, Rachmiel A. Bone Augmentation Techniques for Horizontal and Vertical Alveolar Ridge Deficiency in Oral Implantology. Oral Maxillofac Surg Clin North Am. 2019 May;31(2):163-191. doi: 10.1016/j.coms.2019.01.005.

    PMID: 30947846BACKGROUND

Study Officials

  • Mohammed Aldubai

    Master's Degree Candidate at Faculty of Dentistry, Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evidence-based Dentistry Committe at OMFS dept.

CONTACT

+201001932020surgeryeb@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Candidate of Oral & Maxillofacial Surgery, Faculty of Oral & Dental Medicine

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 17, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

August 1, 2020

Last Updated

July 17, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share