NCT06176417

Brief Summary

Sixteen patients were selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth / teeth in posterior atrophic mandible by dental implant. Patients' grouping: Patients were divided randomly into two equal uniform groups as follow: Group I: Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by decompression technique. Group II: Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by ridge splitting technique using piezosurgery. All patients were evaluated clinically and radiographically at regular time interval immediately, 6 and 12 months after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

December 10, 2023

Last Update Submit

December 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alveolar ridge width

    The ridge width was measured on the cross section view at different time interval from the outer surface of the buccal bone to the outer surface of the lingual bone perpendicular to the line marking the long axis of the implant at implant platform. Changes in alveolar ridge width was measured by subtracting ridge width value after 6 and 12 months from immediate postoperative.

    12 months

Study Arms (2)

group 1

EXPERIMENTAL

Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by decompression technique.

Procedure: horizontal ridge augmentation by decompression technique.

group 2

EXPERIMENTAL

Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by ridge splitting technique using piezosurgery.

Procedure: horizontal ridge augmentation by ridge splitting technique using piezosurgery.

Interventions

Instead of a cover screw, a 2-mm healing abutment was used after implant insertion

group 1

horizontal ridge augmentation was done using piezosurgery tips and bone expanders

group 2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient's cooperation, motivation and good oral hygiene.
  • Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
  • Moderately atrophic posterior mandible (horizontal alveolar dimension is not more than 4 mm at the crest), with minimum 10 mm vertical height.
  • Patients prepared to comply with the follow-up and maintenance programme.
  • Free from history of bruxism / parafunctional habits.

You may not qualify if:

  • Patients with local pathological disease such as cyst, tumor at the planned surgical site.
  • Pregnant patients.
  • Heavy smoker patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sara Elmagraby

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
assistant lecturer of oral and maxillofacial surgery

Study Record Dates

First Submitted

December 10, 2023

First Posted

December 19, 2023

Study Start

August 26, 2021

Primary Completion

August 26, 2023

Study Completion

August 26, 2023

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations