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

November 6, 2023 updated by: Pimduen Rungsiyakull, Chiang Mai University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Chiang Mai, Thailand, 50300
        • Department of Prosthodontics, Faculty of Dentistry, Chiang Mai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Exclusion Criteria:

  • medical and general contraindications for the surgical procedure;
  • heavy smokers (>10 cigarettes/day);
  • an active infection at the implant site.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Customized group
patients who received customized healing abutments following implant placement. customized healing abutments will be fabricated with different macrogeometry and different emergence angle
Procedure: 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.
Experimental: Standard group
patients who received standard titanium healing abutments following implant placement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
soft tissue alteration
Time Frame: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
peri-implant soft tissue change compared to baseline including vertical and horizontal soft tissue alteration by superimposing intraoral scan at different time points
T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
hard tissue alteration
Time Frame: T0 baseline before implant placement, 6month follow up, 12month follow up
peri-implant marginal bone change compared to baseline at different time points by periapical radiograph
T0 baseline before implant placement, 6month follow up, 12month follow up
volumetric alteration
Time Frame: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
peri-implant volumetric change at different time points compared to baseline with superimposing intraoral scan
T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain numerical rating scale
Time Frame: at prosthesis delivery, 2 hours and 24 hours after prosthesis delivery
pain assessment at time of final prosthesis delivery with scale from 0 to 10
at prosthesis delivery, 2 hours and 24 hours after prosthesis delivery
pink esthetic score
Time Frame: T0 baseline before implant placement, 6 month follow up
pink esthetic score change compared to before implant treatment
T0 baseline before implant placement, 6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Pimduen Rungsiyakull, AssocProfDr, Chiang Mai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

December 20, 2023

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Estimated)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 43/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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