NCT06206577

Brief Summary

The aim of the study was to compare efficacy of autogenous onlay and inlay grafts for anterior maxillary horizontal ridge augmentation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

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

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

December 20, 2023

Last Update Submit

January 4, 2024

Conditions

Keywords

onlay graftinginlay grafting

Outcome Measures

Primary Outcomes (1)

  • horizontal ridge augmentation

    CBCT to assess bone gain in mm

    12 months

Study Arms (2)

Group A

EXPERIMENTAL

Seven horizontal anterior maxillary ridge augmentation was done with symphyseal autogenous bone block, which was placed buccally as onlay graft.

Procedure: Horizontal ridge augmentation by symphyseal bone block placed and fixed buccally as onlay graft

Group B

EXPERIMENTAL

Seven horizontal anterior maxillary ridge augmentation was done with symphyseal autogenous bone block, which was interpositioned in space created between buccal and lingual cortex as inlay graft.

Procedure: Horizontal ridge augmentation by symphyseal bone block interpositioned in space created between buccal and lingual cortex as inlay graft

Interventions

autogenous bone block harvested from chin area using piezosurgery and fixed buccally in deficient area with fixation screws

Group A

autogenous bone block harvested from chin area using piezosurgery and fixed in bone split created at deficient area with fixation screws

Group B

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with missing upper anterior tooth / teeth with horizontal ridge dimension range from 2 to 5 mm (measured 2mm below alveolar crest).
  • Adequate vertical height.
  • Having good oral hygiene.
  • being healthy, with no systemic diseases that might contraindicate receiving a dental implant
  • Patients were able to comply with the follow-up and maintenance program

You may not qualify if:

  • Presence of local infection or lesions at site of interest.
  • Dental history of bruxism, or other parafunctional habits.
  • Uncooperative patients.
  • Current chemotherapy or radiotherapy.
  • Patients with aggressive periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura U

Al Mansurah, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer of oral and maxillofacial surgery

Study Record Dates

First Submitted

December 20, 2023

First Posted

January 16, 2024

Study Start

September 1, 2020

Primary Completion

September 15, 2022

Study Completion

May 26, 2023

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations