NCT06585852

Brief Summary

The aim of the present study is to evaluate the efficacy of xenograft alone or xenograft mixed with Arginylglycylaspartic acid (RGD) , in horizontal ridge augmentation with split-crest technique, for implant placement.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
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

August 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

September 1, 2024

Last Update Submit

September 3, 2024

Conditions

Implant Dentistry

Outcome Measures

Primary Outcomes (1)

  • ISQ measurement for implant stability

    Evaluate implant stability by osstell device

    At time of surgery, at loading and 3 months after loading.

Secondary Outcomes (1)

  • Bone density around dental implants.

    At time of loading and 3 months after loading

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Xenograft alone with split-crest technique by ultrasonic bone surgery and implant placement.

Drug: XenograftProcedure: Split crest technique

Study Group

EXPERIMENTAL

Xenograft mixed with RGD with split-crest technique by ultrasonic bone surgery and implant placement.

Drug: RGDDrug: XenograftProcedure: Split crest technique

Interventions

RGDDRUG

Study group main material

Also known as: Arginylglycylaspartic acid
Study Group
XenograftDRUG

Scaffold material of choice

Control GroupStudy Group
Split crest techniquePROCEDURE

Piezoelectric surgery

Control GroupStudy Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults (age 18-30) exhibiting initial insufficiently bone width.
  • Patients with good oral hygiene.
  • Patients must be free from systemic diseases that may influence the outcome of the therapy.
  • Patients with bony horizontal defects alone, Class III \& IV.

You may not qualify if:

  • Heavy smokers.
  • Patient treated by immunosuppressive chemotherapy or radio therapy,
  • Allergy to any material or medication used in the study.
  • Pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar University of Cairo

Cairo, Nasr City, Egypt

RECRUITING

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Central Study Contacts

Mahmoud Taha, PHD

CONTACT

01225864104info@azhar.edu.eg

Ibrahim Sabri

CONTACT

01007809113info@azhar.edu.eg

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
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 1, 2024

First Posted

September 19, 2024

Study Start

August 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 15, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

EG(1)