NCT06529653

Brief Summary

The current study aimed to evaluate both the quality and quantity of gained and maintained bone width after ridge splitting utilizing autogenic bone wedges versus mixed bone particles for horizontal ridge augmentation in the anterior esthetic zone.

Trial Health

57
Monitor

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 Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

July 24, 2024

Last Update Submit

July 26, 2024

Conditions

Horizontal Ridge Deficiency

Keywords

ridge splitting, bone wedge, mixed bone particles, horizontally deficient ridge, aesthetic zone, ridge augmentation.

Outcome Measures

Primary Outcomes (1)

  • bone width in (mm) by cone beam pre, immediate post operative and 6 months postoperative

    after ridge augmentation in both groups, the bone width will be measured immediately postoperatively and 6 months postoperatively with cone beam and the measurements of the three intervals (pre-, immediate and 6 months postoperatively) will be compared in both groups to evaluate the amount of gained and maintained bone width

    6 months

Secondary Outcomes (1)

  • percentage of areas of new bone (%)

    6 months

Study Arms (2)

intervention group

OTHER

the group using an autogenous bone wedge harvested from the chin interpositioned between split cortices in the anterior maxilla to manage the horizontal deficiency of the ridge.

Procedure: autogenous bone wedge

control group

OTHER

the group used mixed autogenic and xenogenic bone particles that interposed between split cortices in anterior maxilla to manage the horizontal deficiency of the ridge

Procedure: autogenous bone wedge

Interventions

autogenous bone wedgePROCEDURE

autogenous bone block harvested from chin and adjusted to be wedged intercortical in split ridge

control groupintervention group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All patients possessed partially edentulous anterior maxillary ridge with the following criteria
  • The anterior maxillary vertical dimension was more than ten mm measured from the alveolar crest to the basal bone of the maxilla.
  • The horizontal alveolar dimension varies from 3-5 mm at the crest and 6-8 mm at the basal part of the ridge measured from the labial cortex to the lingual cortex.
  • All patients were free from any medical conditions that may affect bone healing .
  • No local pathosis that may interfere with bone healing.
  • No previous grafting procedures at the indicated edentulous ridge.

You may not qualify if:

  • Patients suffering from any systemic disease that may affect bone healing. 2- Patients with less than 3mm labio palatal alveolar ridge width. 3- Ridge with inadequate vertical bone height. 4- Presence of any local pathosis that may interfere with bone healing. 5- Patients unable to continue the whole follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

oral and maxillo facial Surgery Department; Faculty of dentistry, Cairo University.

Cairo, Egypt

RECRUITING

Related Publications (2)

  • Atef M, Osman AH, Hakam M. Autogenous interpositional block graft vs onlay graft for horizontal ridge augmentation in the mandible. Clin Implant Dent Relat Res. 2019 Aug;21(4):678-685. doi: 10.1111/cid.12809. Epub 2019 Jul 1.

    PMID: 31260166BACKGROUND

  • Omara M, Mekhemer S, Mansour S, Ahmed Y. Ridge splitting using autogenous bone wedge versus the conventional intercortical augmentation technique in horizontally deficient anterior maxilla: a randomized clinical trial. BMC Oral Health. 2025 Jun 21;25(1):955. doi: 10.1186/s12903-025-06345-z.

    PMID: 40544250DERIVED

Related Links

Central Study Contacts

yasmin ahmed, B.D.S

CONTACT

01065273456yasmin.ahmed@dentistry.cu.edu.eg

Mohamed Omara, PHD

CONTACT

01144452862

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
masiomara

Study Record Dates

First Submitted

July 24, 2024

First Posted

July 31, 2024

Study Start

October 30, 2022

Primary Completion

August 30, 2024

Study Completion

December 30, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

EG(1)