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Clinical Trials/NCT06125418
NCT06125418
Enrolling by Invitation
N/A

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

Chiang Mai University1 site in 1 country60 target enrollmentJune 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peri-implant Tissue Response With Use of Customized Healing Abutments
Sponsor
Chiang Mai University
Enrollment
60
Locations
1
Primary Endpoint
soft tissue alteration
Status
Enrolling by Invitation
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
December 20, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pimduen Rungsiyakull

Associate Professor

Chiang Mai University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • pain numerical rating scale(at prosthesis delivery, 2 hours and 24 hours after prosthesis delivery)
  • pink esthetic score(T0 baseline before implant placement, 6 month follow up)

Study Sites (1)

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