Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone

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

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-12-20

Brief Summary

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The goal of this clinical trial is to evaluate effect of customized healing abutment in patients who need single implant reconstruction. The main question it aims to answer is:

• effect of customized healing abutment on peri-implant soft and hard tissue Participants will received customized healing abutments before final prostheses delivery.

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Detailed Description

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Patients who need single implant restoration will be received one- stage implant placement with utilization of customized healing abutment. Data collection about change in hard and soft tissue will be collected digitally at several times points. Patients will received single crown on implant as final prosthesis. Change in peri-implant tissue will be analyzed with digital softwares.

Conditions

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Peri-implant Tissue Response With Use of Customized Healing Abutments

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients in each group will received different types of customized healing abutment

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Customized group

patients who received customized healing abutments following implant placement. customized healing abutments will be fabricated with different macrogeometry and different emergence angle

Group Type EXPERIMENTAL

customized healing abutment

Intervention Type PROCEDURE

patients will undergoes one-stage implant placement with customized healing abutments with different macrogeometry and emergence angle made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.

Standard group

patients who received standard titanium healing abutments following implant placement

Group Type EXPERIMENTAL

standard healing abutment

Intervention Type PROCEDURE

patients will undergoes one-stage implant placement with standard titanium healing abutment made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.

Interventions

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customized healing abutment

patients will undergoes one-stage implant placement with customized healing abutments with different macrogeometry and emergence angle made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.

Intervention Type PROCEDURE

standard healing abutment

patients will undergoes one-stage implant placement with standard titanium healing abutment made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ≥18 years of age;
* patients who needed a single implant placing therapy in maxillary or mandibular arch except in third molar regions
* sufficient mesial distal and interocclusal space for placement of the implant and definitive restoration;
* had sufficient apical bone to place an implant with minimum primary stability of 30 Ncm.