NCT06727591

Brief Summary

The aim of this study was to compare clinically and radiographically bone gain, healing of the surgical site, healing of the grafted bone and stability of the grafted area following horizontal ridge augmentation at anterior mandible using split bone block from the chin area.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

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 10, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 4, 2024

Last Update Submit

December 9, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Postoperative Pain

    It was assessed through a 10-point Visual Analogue Scale (VAS). The categories were as follows (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

    up to 2 weeks

  • Implant stability

    Implant stability was measured using Osstell. Osstell measures the resonance frequency which indicated the implant stability. It has a scale from 1 to 100 where: * \<60 is considered low stability. * 60 \~ 69 is considered intermediate stability. * ≥ 70 is considered high stability

    up to 3 months

  • Amount of horizontal bone gain

    This was measured on cone beam computed tomography (CBCT) by comparing pre- and post-operative bone width at specific levels around the implant.

    up to 4 months

Study Arms (1)

Horizontal Ridge Augmentation with Split Bone Block

EXPERIMENTAL
Procedure: Split Bone Block Technique

Interventions

An intraoral crestal incision with/out vertical arms was performed on alveolar ridge using blade no.15. After flap reflection, patroning the defect to help guide the area to be grafted from the donor site. At the chin area (donor site) unicortical cuts will be made at least 5 mm inferior to root tips, 5 mm superior to inferior border of mandible and 5 mm away from the mental foramen. The graft was luxated and split into two bone shells each 1 \~ 2 mm in thickness using disc. The bone shells and the donor site were scrapped for autogenous graft particles. Decortication of the recipient site. The graft was stabilised into the recipient site using two or more self tapping titanium screws placed midway corono-apical in the bone shell following the ridge contour. The autogenous particles were packed into the space between the split bone block and the ridge. Collagen sponge was used to cover the donor site. After 4 months the site was approached for implant placement using crestal incision

Horizontal Ridge Augmentation with Split Bone Block

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with missing anterior mandibular teeth
  • horizontal bone width \< 5 mm
  • Adequate zone of keratinized tissue

You may not qualify if:

  • Presence of infection or periapical lesions in adjacent teeth
  • Medically compromised patients with a condition that affect the procedure
  • Insufficient inter-arch distance
  • Bruxism or clenching
  • Alcoholism
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 11, 2024

Study Start

October 10, 2023

Primary Completion

October 20, 2024

Study Completion

October 20, 2024

Last Updated

December 11, 2024

Record last verified: 2024-12

Locations