search
Back to results

Evaluation of Vertical Height in Anterior Maxillary Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement

Primary Purpose

Alveolar Bone Resorption

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement
Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Resorption focused on measuring Vertical bone augmentation, Inlay bone graft, Dental Implants, Sandwich Osteotomy

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sandwich osteotomy with simultaneous implant placement

    Sandwich osteotomy using micro-plates fixation

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Patient Satisfaction: scale from 1 to 10
    Measured on a scale from 1 to 10

    Full Information

    First Posted
    July 15, 2019
    Last Updated
    July 16, 2019
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04022538
    Brief Title
    Evaluation of Vertical Height in Anterior Maxillary Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement
    Official Title
    Evaluation of Vertical Bone Augmentation Using Anterior Maxillary Segmental Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement, A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2019 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Fixation plates are usually used to support the segmentalized bone segment during vertical bone augmentation using sandwich osteotomy and inlay bone grafting; to minimize movement of the bone segment and allow for new bone formation. Therefore, the aim of this study is to evaluate vertical bone height achieved at the anterior maxilla in vertical segmental sandwich osteotomy with simultaneous implant placement versus the same technique using fixation plates. Description of Sandwich Osteotomy procedure to be done: A full thickness pyramidal flap with buccal paracrestal incision and two vertical releasing incisions slightly divergent to each other will be made. Then the mucoperiosteal flap will be reflected exposing the whole buccal cortical plate without reflection of the palatal mucosa. The palatal mucosa will not be reflected to avoid disturbance of blood supply to the mobilized segment for proper healing. With a Tungsten carbide disc - 1 mm in thickness and 10 mm in diameter - the alveolar bone will be segmented using a horizontal cut 3 to 5 mm apical to the crest of the ridge, and two lateral vertically oblique cuts 1-2 mm away from adjacent teeth roots slightly converging toward the alveolar crest or almost parallel to each other; thus creating a trapezoid-shaped bone segment pedicled on the attached palatal tissues. The horizontal and the two vertical cuts will then be revised using a set of graduated ridge splitting (fine chisels) osteotomes of sequential width and a light weight mallet to ensure that the surgical cuts are down to spongy bone. The segment will then be mobilized crestally, pedicled on the non-reflected palatal tissue.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alveolar Bone Resorption
    Keywords
    Vertical bone augmentation, Inlay bone graft, Dental Implants, Sandwich Osteotomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sandwich osteotomy with simultaneous implant placement
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sandwich osteotomy using micro-plates fixation
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement
    Other Intervention Name(s)
    Inlay alveolar bone grafting with simultaneous implant placement
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Final Vertical Alveolar ridge height
    Description
    Measured in millimeters from the crest of the alveolar ridge to the floor of nasal cavity using cone-beam computed tomography
    Time Frame
    4 months postoperatively
    Secondary Outcome Measure Information:
    Title
    Patient Satisfaction: scale from 1 to 10
    Description
    Measured on a scale from 1 to 10
    Time Frame
    4 months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: • 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Evidence-based Dentistry Committe at OMFS dept.
    Phone
    +201001932020
    Email
    surgeryeb@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammed Aldubai
    Organizational Affiliation
    Master's Degree Candidate at Faculty of Dentistry, Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18091161
    Citation
    Bashutski JD, Wang HL. Common implant esthetic complications. Implant Dent. 2007 Dec;16(4):340-8. doi: 10.1097/ID.0b013e318159ca05.
    Results Reference
    background
    PubMed Identifier
    5233859
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30019829
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18646092
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17695343
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16413903
    Citation
    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. Erratum In: J Oral Maxillofac Surg. 2006 Jun;64(6):997.
    Results Reference
    background
    PubMed Identifier
    2639859
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27008252
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24321312
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28938030
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30411842
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24451333
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28526551
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24977256
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    5224784
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10555808
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28208057
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17622001
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28573552
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12956475
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24575743
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28002717
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30947846
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Evaluation of Vertical Height in Anterior Maxillary Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement

    We'll reach out to this number within 24 hrs