Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts: Randomized Controlled Clinical Trial

NCT ID: NCT06653868

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-20

Study Completion Date

2026-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In patients with a single non restorable tooth, does filling the peri-implant buccal gap with alloplastic sticky grafts result comparable results compared to xenogenic sticky grafts?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The buccal aspect of the dental implant has great importance, especially in the aesthetic zone, because the buccal bone is very thin especially in the anterior maxilla and its resorption can result in recession of the soft tissue. A gap occurs in immediately placed implant due to discrepancy between the dimensions of the extraction socket and the implant. Augmentation of the buccal gap decreases the amount of buccal bone resorption and soft tissue recession . Filling the peri-implant defects has been widely discussed to prevent further bone loss. The use of biologic materials such as platelet rich fibrin can enhance the quality of alloplastic bone grafts to give comparable effect when compared to xenogenic grafts.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Loss, Alveolar

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

immediate implant placement surgery with filling the gap distance with alloplastic sticky graft

immediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with alloplast.

Group Type EXPERIMENTAL

dental implant with bone augmentation

Intervention Type PROCEDURE

gap distance augmentation with bone graft

immediate implant placement surgery with filling the gap distance with xenogenic sticky bone

immediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with xenograft.

Group Type EXPERIMENTAL

dental implant with bone augmentation

Intervention Type PROCEDURE

gap distance augmentation with bone graft

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dental implant with bone augmentation

gap distance augmentation with bone graft

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

gap distance augmentation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients with healthy systemic condition (Mazzotti et al., 2023).
2. Age from 20-50 years old
3. Patients must be free of any systemic disease which could influence the surgical procedure.
4. Tooth involved in the esthetic zone.
5. Sufficient hard and soft tissue volume in vertical and buccolingual direction
6. Natural teeth adjacent to the involved tooth will be required to be free from infection.
7. Controlled oral hygiene.
8. Indication for tooth extraction included (Degidi et al., 2012);

* Endodontic failures
* Untreatable caries
* Non- restorable teeth
* Vertical root fracture
* Remaining roots

Exclusion Criteria

\- 1.Pregnant females 2.Smokers (Khuller, 2009) 3.Unmotivated and uncooperative patients with poor oral hygiene 4.Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.

5.Presence of acute dento-alveolar infection.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

bassant mohye

bassant mohye

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Cairo, , Egypt

Site Status RECRUITING

Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

bassant mohye, phd candidate

Role: primary

01006744545

bassant mohye, phd candidate

Role: primary

01006744545

cairo university

Role: backup

0223646375

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

per631

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.