NCT06125938

Brief Summary

The goal of this clinical trial is to compare in patients with atrophied anterior maxilla, bone augmentation techniques ( gold standard bone block and tent pole technique). The main question it aims to answer is : Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior maxilla?

  • primary objective to assess amount of bone gain
  • secondary objective assess bone quality Participants will be randomly divided into two groups study group ( tent pole technique) and control group ( bone block) - each group will be followed up monthly for soft tissue dehiscence and after 6 month to assess bone gain and bone quality and then implant placement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

October 27, 2023

Last Update Submit

November 5, 2023

Conditions

Keywords

bone augmentation ,tent pole

Outcome Measures

Primary Outcomes (1)

  • Bone Gain

    to assess amount of bone gain before and after 6 month of the surgical procedure

    6 month

Secondary Outcomes (1)

  • Bone quality evaluation

    6 month post-operative

Other Outcomes (1)

  • soft tissue dehiscence

    monthly for 6 months post-operative

Study Arms (2)

tent pole technique

EXPERIMENTAL

The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies

Procedure: tent pole technique

autogenous bone block technique

ACTIVE COMPARATOR

Bone block graft has been the gold standard for restoring deficient regions.

Procedure: Autogenous bone block technique

Interventions

The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies

tent pole technique

Bone block graft has been the gold standard for restoring deficient regions.

autogenous bone block technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • systemically healthy patients (American Society of Anesthesiologists -ASA I and II); older than 18 years
  • Patients with atrophic anterior maxilla ,with initial ridge wi¬dth of ≤ 5 mm and moderate bone height as diagnosed at the time of digital implant planning
  • No intraoral soft and hard tissue pathology.
  • Cone Beam Computer Tomography scan before and after bone augmentation.
  • Apprehensive to be in the study

You may not qualify if:

  • Bad oral hygiene.
  • smokers (\>10 cigarettes/day);
  • Existence of a bone metabolic disease; currently taking drugs that might influence bone metabolism
  • Radiotherapy or chemotherapy for malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Youmna M Abdelhady

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master candidate

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 9, 2023

Study Start

October 1, 2023

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations