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

Not Applicable

• Conditions: Peri-implant Tissue Response With Use of Customized Healing Abutments
• Interventions: Procedure: standard healing abutment; Procedure: customized healing abutment

• Registration Number: NCT06125418
• Lead Sponsor: Chiang Mai University

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.

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-06
• Last Update Submitted: 2023-11-06
• Study First Posted: 2023-11-09
• Last Update Posted: 2023-11-09
• Primary Completion: 2023-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard group	standard healing abutment	patients who received standard titanium healing abutments following implant placement
Customized group	customized healing abutment	patients who received customized healing abutments following implant placement. customized healing abutments will be fabricated with different macrogeometry and different emergence angle

Primary Outcome Measures

Name	Time	Method
soft tissue alteration	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	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	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 Outcome Measures

Name	Time	Method
pain numerical rating scale	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
pink esthetic score	T0 baseline before implant placement, 6 month follow up	pink esthetic score change compared to before implant treatment

Trial Locations

Locations (1)

Department of Prosthodontics, Faculty of Dentistry, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand