NCT06711250

Brief Summary

The current st udy's objective was to validate the repeated effect of i PRF with autogenous bone on the of gingival thickness , width a n d volumetric bone changes durig maxillary alveolar augmentation using cone beam computer tomography (CBCT). Patients and methods:

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 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

April 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 22, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

A lveolar ridge defect , Khoury technique Guided bone regeneration, i PRF, CBCT analysis

Outcome Measures

Primary Outcomes (1)

  • width of the alveolar ridge

    CBCT will be used to assess the width of the alveolar ridge

    baseline, 6 months & 9 months

Secondary Outcomes (1)

  • volumetric analysis of bone

    at baseline, 6 and 9 months

Study Arms (2)

control

ACTIVE COMPARATOR

bone grafting

Procedure: khoury technique

study

ACTIVE COMPARATOR

bone grafting \& i PRF

Procedure: khoury technique with i-PRF injections

Interventions

autogenous bone augmentation

control

autogenous bone augmentation with repeated i-PRF injections

study

Eligibility Criteria

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

You may qualify if:

  • patients who have a horizontal or vertical alveolar ridge deficiency

You may not qualify if:

  • patients showing any signs of active periodontal disease
  • patients on long term corticosteroid therapy,
  • patients taking bone metabolism drugs
  • patients suffering from any systemic illness that may impact bone repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry , Al Azhar Univeristy For Girls

Cairo, Heliopolis - Cairo, 123456, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Zainab H Abdel Rahman, Phd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2024

First Posted

December 2, 2024

Study Start

April 1, 2024

Primary Completion

September 1, 2024

Study Completion

November 1, 2024

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations