NCT03629860

Brief Summary

Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

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

May 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2019

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

August 6, 2018

Last Update Submit

August 13, 2018

Conditions

Keywords

Atrophic, augmetation, bone regeneration

Outcome Measures

Primary Outcomes (1)

  • width and height of the bone gained by the procedure and the new measures from a physiologic vital structures e.g( nasal floor, maxillary sinus or even occlusal plan)

    new bone formation

    6 months

Secondary Outcomes (1)

  • Histomorphometric analysis bone area percent

    6 months

Study Arms (2)

ascending ramus group

ACTIVE COMPARATOR

* Local anesthesia will be given to the patient * flap will be reflected to expose the facial wall of the maxilla then The ascending ramus is accessed. * A disc bur will be used to make a rectangular osteotomy * The block bone graft is removed from ascending ramus to recipient site the fixed by mini screws * Doner site flap is closed by using interrupted internal sutures. * after atrophic maxillary alveolar ridge augmentation,sub mucosal periosteal releasing cuts is done * Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7 days

Procedure: Atrophic maxillary alveolar ridge augmentation

Chin Group

ACTIVE COMPARATOR

* Local anesthesia will be given to the patient * flap will be reflected to expose the facial wall of the maxilla then The chin is accessed. * A disc bur will be used to make a rectangular osteotomy * The block bone graft is removed from chin to recipient site the fixed by mini screws * Doner site flap is closed by using interrupted internal sutures * after atrophic maxillary alveolar ridge augmentation,submucosal periosteal releasing cuts is done * Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7days

Procedure: Atrophic maxillary alveolar ridge augmentation

Interventions

Autogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges

Chin Groupascending ramus group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with atrophic maxilla with residual bone height from 3 to 4mm.
  • Both sexes

You may not qualify if:

  • Intraoral soft and hard tissue pathology.
  • Systemic condition that contraindicate implant basement.
  • Psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Al-Manial, 11553, Egypt

RECRUITING

Related Publications (10)

  • Ali SA, Karthigeyan S, Deivanai M, Kumar A. Implant rehabilitation for atrophic maxilla: a review. J Indian Prosthodont Soc. 2014 Sep;14(3):196-207. doi: 10.1007/s13191-014-0360-4. Epub 2014 Apr 22.

    PMID: 25183902BACKGROUND
  • Sorni M, Guarinos J, Garcia O, Penarrocha M. Implant rehabilitation of the atrophic upper jaw: a review of the literature since 1999. Med Oral Patol Oral Cir Bucal. 2005 Apr 1;10 Suppl 1:E45-56. English, Spanish.

    PMID: 15800467BACKGROUND
  • Dym H, Huang D, Stern A. Alveolar bone grafting and reconstruction procedures prior to implant placement. Dent Clin North Am. 2012 Jan;56(1):209-18, x. doi: 10.1016/j.cden.2011.09.005.

    PMID: 22117951BACKGROUND
  • Bellini CM, Romeo D, Galbusera F, Agliardi E, Pietrabissa R, Zampelis A, Francetti L. A finite element analysis of tilted versus nontilted implant configurations in the edentulous maxilla. Int J Prosthodont. 2009 Mar-Apr;22(2):155-7.

    PMID: 19418861BACKGROUND
  • Bidra AS, Almas K. Mini implants for definitive prosthodontic treatment: a systematic review. J Prosthet Dent. 2013 Mar;109(3):156-64. doi: 10.1016/S0022-3913(13)60035-9.

    PMID: 23522364BACKGROUND
  • Chiriac G, Herten M, Schwarz F, Rothamel D, Becker J. Autogenous bone chips: influence of a new piezoelectric device (Piezosurgery) on chip morphology, cell viability and differentiation. J Clin Periodontol. 2005 Sep;32(9):994-9. doi: 10.1111/j.1600-051X.2005.00809.x.

    PMID: 16104964BACKGROUND
  • Enneking WF, Eady JL, Burchardt H. Autogenous cortical bone grafts in the reconstruction of segmental skeletal defects. J Bone Joint Surg Am. 1980 Oct;62(7):1039-58.

    PMID: 7000788BACKGROUND
  • Menini M, Signori A, Tealdo T, Bevilacqua M, Pera F, Ravera G, Pera P. Tilted implants in the immediate loading rehabilitation of the maxilla: a systematic review. J Dent Res. 2012 Sep;91(9):821-7. doi: 10.1177/0022034512455802. Epub 2012 Jul 31.

    PMID: 22851285BACKGROUND
  • Peleg M, Mazor Z, Garg AK. Augmentation grafting of the maxillary sinus and simultaneous implant placement in patients with 3 to 5 mm of residual alveolar bone height. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):549-56.

    PMID: 10453671BACKGROUND
  • Topolovec-Vranic J, Canzian S, Innis J, Pollmann-Mudryj MA, McFarlan AW, Baker AJ. Patient satisfaction and documentation of pain assessments and management after implementing the adult nonverbal pain scale. Am J Crit Care. 2010 Jul;19(4):345-54; quiz 355. doi: 10.4037/ajcc2010247.

    PMID: 20595216BACKGROUND

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Y Yousri, Bsd

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.D.S,Principal investigator,dentist

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 14, 2018

Study Start

May 1, 2018

Primary Completion

February 8, 2019

Study Completion

April 9, 2019

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations