NCT06416605

Brief Summary

This study is designed to evaluate the clinical and radiographical outcome of tooth shell for alveolar ridge reconstruction in maxilla as an alternative to traditional autologous bone shell graft.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 12, 2024

Last Update Submit

May 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • horizontal alveolar width measurements

    Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement.

    6 months

Study Arms (2)

group A

EXPERIMENTAL

Horizontal bone augmentation will be done by bone shell technique

Procedure: Maxillary Alveolar Ridge Augmentation

group B

EXPERIMENTAL

Horizontal bone augmentation will be done by autogenous tooth shell technique

Procedure: Maxillary Alveolar Ridge Augmentation

Interventions

using tooth graft or bone graft to increase alveolar ridge width to be able to insert dental implant

group Agroup B

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 1- One or two maxillary extracted teeth with crestal bone width of 4 mm or less.
  • Age ranging from 18\_50 years 3- 3- Adequate oral hygiene. 4- Non smoking patients. 5-Free from any pathological lesions related to the tooth to be extracted. 6- Physically fit to withstand the whole procedure.

You may not qualify if:

  • Active infection in the site to be treated. 2- Patients on chemotherapy or radiotherapy. 3- Alcohol or drug abuse. 4- Patients who have systemic disorders that interfere with bone healing {uncontrolled diabetes mellitus, autoimmune disease,
  • etc.} 5- Pregnancy. 6- Patients with bone disease. 7- Patients with parafunctional habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heba Elsheikh

Al Mansurah, Egypt

Location

Related Publications (1)

  • Awad KAI, Tawik MA, Hussein MM, El-Farag SAA, Sameaa SESA. Tooth shell versus bone shell technique for horizontal maxillary alveolar ridge augmentation. BMC Oral Health. 2025 Apr 25;25(1):642. doi: 10.1186/s12903-025-05940-4.

MeSH Terms

Interventions

Alveolar Ridge Augmentation

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

May 12, 2024

First Posted

May 16, 2024

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

December 30, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations