MedDataX Logo

Evaluation Of Peri-Implant Emergence Profile Conditioned With Two Different Prosthetic Techniques

NCT ID: NCT04329156

Last Updated: 2023-12-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-25

Study Completion Date

2021-07-22

Brief Summary

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

The aim of this study is to evaluate and compare two prosthetic conditioning techniques to create natural-like peri-implant emergence profile.

Detailed Description

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

Twenty four patients having a non-restorable tooth will be rehabilitated with flapless immediate implant placement after tooth extraction. The emergence profile will be conditioned with either a stock or a customized healing abutment. A definitive screw retained restoration will be inserted 4 months postoperatively. Peri-implant tissues will be evaluated using pink and white esthetic score, radiographs and periodontal parameters at 3,6 and 12 months after implant placement.

Conditions

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

Dental Implants

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

SINGLE

Participants

Study Groups

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

Digitally Flip Technique

Group Type EXPERIMENTAL

Digitally Flip Technique

Intervention Type OTHER

A prefabricated shell will be made then after implant placement, the shell will be attached to a plastic abutment using flowable composite to make a customized healing abutment.

Stock Healing Abutment

Group Type ACTIVE_COMPARATOR

Stock Healing Abutment

Intervention Type OTHER

After implant placement, a stock healing abutment will be placed onto the implant and screwed on. It will be selected to be 1-2 mm above the gingival margin and slightly smaller in diameter than the intended final restoration.

Interventions

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

Digitally Flip Technique

A prefabricated shell will be made then after implant placement, the shell will be attached to a plastic abutment using flowable composite to make a customized healing abutment.

Intervention Type OTHER

Stock Healing Abutment

After implant placement, a stock healing abutment will be placed onto the implant and screwed on. It will be selected to be 1-2 mm above the gingival margin and slightly smaller in diameter than the intended final restoration.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Presence of non-restorable maxillary anterior or premolar tooth and its healthy contra-lateral.
* The gingival contour of the tooth to be extracted should be in harmony with the healthy contra-lateral tooth.
* Having thick gingival biotype.

Exclusion Criteria

* Any medical disorder that could interfere with osseointegration or soft tissue healing.
* Active oral infections or periodontal disease.
* Presence of dehiscence or fenestration defects related to the tooth to be extracted.
* Poor oral hygiene.
* Heavy smokers (\>10 cigarette / day).
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Alexandria University

OTHER

Sponsor Role collaborator

Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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

Nourhan M.Aly

Dental Public Health clinical instructor and study statistician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muhammed Badee, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Mohamed M Khamis, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Ahmed A Abdelhakim, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Rania Abdelaziz, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Locations

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

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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

Egypt

Other Identifiers

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

digital flip vs stock healing

Identifier Type: -

Identifier Source: org_study_id