The Influence of Vertical Implant Position on the Marginal Bone Loss in Thick Versus Thin Phenotype.

NCT ID: NCT06177275

Last Updated: 2023-12-20

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-02-01

Brief Summary

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

Multiple clinical studies have established high survival rates and tremendous predictability of dental implant treatment (Schiegnitz and Al-Nawas 2018). However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone (Vermylen et al. 2003)and several esthetic factors have been evaluated to contribute to an esthetic appearance. Among these, the midfacial soft tissue level is considered to be one of the most important factors; Cosyn and co-workers reported that among factors including soft tissue phenotype, the midfacial recession was associated with the position of the implant (Cosyn et al. 2012).

Therefore, subcrestal implant placement has been advocated as it has been associated with the reduction of crestal bone loss in cases with decreased soft tissue thickness. If the vertical soft tissues on the crest of the alveolar ridge are 2 mm or less at the time of implant placement, implants will undergo unavoidable bone resorption by establishing sufficient biologic protection. Another option was proposed by Linkevicius et al, who introduced the subcrestal implant placement as a method to accommodate the problem of thin soft tissues.(Linkevicius et al. 2020).

Limiting the extent of peri-implant bone loss has been recognized for decades to be an important aspect of long-term implant success, and stable peri-implant bone conditions play an important role in maintaining esthetics (Laurell and Lundgren, 2011).

The opinion expressed widely in the scientific literature has been that subcrestal implant placement leads to increased crestal bone resorption. However, clinical studies addressing the implant placement depth in relation to crestal bone have been rare. Data on subcrestal versus crestal placement have mostly come from animal studies. Even fewer data are available regarding the effects of crestal versus subcrestal positioning of platform-switched implants (Cochran et al., 2009).

This study aims to compare the effect of different vertical implant position with immediate provisionalization on marginal bone loss thin and thick vertical tissue biotype.

Detailed Description

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

Conditions

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

Dental Implant Vertical Position Esthetic Zone Bounded Edentulous Area

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

DOUBLE

Participants Outcome Assessors

Study Groups

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

Thin vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal

In Thin vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.

Group Type EXPERIMENTAL

Placement of BLX implants 2 mm sub-crestal i

Intervention Type PROCEDURE

Placement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.

Thin vertical soft tissue biotype, Placement of BLX implants equicrestal

In Thin vertical soft tissue biotype, Placement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.

Group Type ACTIVE_COMPARATOR

Placement of BLX implants equicrestal

Intervention Type PROCEDURE

Placement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.

Thick vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal

In Thick vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.

Group Type EXPERIMENTAL

Placement of BLX implants 2 mm sub-crestal i

Intervention Type PROCEDURE

Placement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.

Thick vertical soft tissue biotype, Placement of BLX implants equicrestal

In Thick vertical soft tissue biotype, Placement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.

Group Type ACTIVE_COMPARATOR

Placement of BLX implants equicrestal

Intervention Type PROCEDURE

Placement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.

Interventions

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

Placement of BLX implants 2 mm sub-crestal i

Placement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.

Intervention Type PROCEDURE

Placement of BLX implants equicrestal

Placement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Patients with single missing upper anterior or premolar teeth
* Patients with minimum buccolingual width of 6 mm and mesiodistal width of 6mm
* Patients with healthy systemic conditions.
* Patients older than 18 years.
* Good oral hygiene.
* Accepts one year follow-up period (cooperative patients).
* The patient provides informed consent.
* Adequate Inter-arch space for implant placement.
* Favorable occlusion (no traumatic occlusion).
* Absence of allergy to the prescribed medications.

Exclusion Criteria

* Patients with inadequate bone volume and/ or quality
* Patients with local root remnants
* Patients with inadequate wound healing
* Patients with signs of acute infection related to the area of interest.
* Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
* Heavy smokers patients (more than 10 cigarettes per day) (Lambert, Morris and Ochi, 2000).
* Metabolic diseases such as diabetes or hyperthyroidism as well as systemic medications such as chemotherapy or bisphosphonates
* Pregnant or nursing women.
* Uncooperative patients.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 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.

Nesma Mohamed Fouad Shemais

Lecturer in the department of Oral Medicine & Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Faculty of Dentistry, Cairo University

Giza, , 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.

nesma m Shemais, PhD

Role: primary

Other Identifiers

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

NHR

Identifier Type: -

Identifier Source: org_study_id