NCT05620459

Brief Summary

The study aims toward using autogenous bone grafts to solve decreased bone quantity in anterior maxilla while allowing the patient to recieve implants simultaneously (same time of grafting).

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

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

October 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 7, 2022

Last Update Submit

November 12, 2022

Conditions

Ridge Augmentation

Outcome Measures

Primary Outcomes (1)

  • Bone quantity (crestal bone) height)

    Cone beam

    3 months after operation day

Secondary Outcomes (1)

  • Bone quality (bone density at the ring alveolus interface)

    3 months after operation day

Study Arms (1)

Interventional arm (Ridge augmentation with simultaneous implant placement)

EXPERIMENTAL

Chin bone ring is harvested using surgical guide to augment 1. anterior maxillary defective recent extraction sockets OR 2. remaining roots that need extraction and are accompanied with labial bone loss Associated with simultaneous implant placement with the aid of surgical guides

Procedure: Ridge augmentation using chin bone ring with simultaneous implant placement

Interventions

Ridge augmentation using chin bone ring with simultaneous implant placementPROCEDURE

surgical guides are to be used to harvest chin bone ring, the rings are to be used for bone augmentation in extraction sockets (salama and salama classsification type II),simultaneously implant placement.

Interventional arm (Ridge augmentation with simultaneous implant placement)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with non-restorable teeth in the maxillary anterior region with insufficient buccal bone height or buccal bone defect.
  • Patients who have given their consent for this trial.
  • Both genders males and females will be included.

You may not qualify if:

  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

cairo University

Cairo, cairo/Manial, 11553, Egypt

RECRUITING

Related Publications (4)

  • Yuce MO, Adali E, Turk G, Isik G, Gunbay T. Three-dimensional bone grafting in dental implantology using autogenous bone ring transplant: Clinical outcomes of a one-stage technique. Niger J Clin Pract. 2019 Jul;22(7):977-981. doi: 10.4103/njcp.njcp_652_18.

    PMID: 31293264BACKGROUND

  • Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.

    PMID: 26644216BACKGROUND

  • Simpson KT, Bryington M, Agusto M, Harper M, Salman A, Schincaglia GP. Computer-Guided Surgery Using Human Allogenic Bone Ring With Simultaneous Implant Placement: A Case Report. Clin Adv Periodontics. 2020 Mar;10(1):16-22. doi: 10.1002/cap.10073. Epub 2019 Oct 14.

    PMID: 31513341BACKGROUND

  • Stevens MR, Emam HA, Alaily ME, Sharawy M. Implant bone rings. One-stage three-dimensional bone transplant technique: a case report. J Oral Implantol. 2010;36(1):69-74. doi: 10.1563/AAID-JOI-D-09-00029.

    PMID: 20218871BACKGROUND

Study Officials

  • Mostafa M gad, bds

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa M gad, BDS

CONTACT

201000264683mostafa.gad@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator (Master of science student oral and maxillofacial surgery)

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 17, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

November 17, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)