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

NCT06125418 | Unknown DMC

• 1 other identifier: 43/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Tissue Response With Use of Customized Healing Abutments

Keywords

dental implant, customized healing abutment

Outcome Measures

Primary Outcomes (3)

• soft tissue alteration

  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

  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

  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 Outcomes (2)

• 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 Arms (2)

Customized group

EXPERIMENTAL

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

Standard group

EXPERIMENTAL

patients who received standard titanium healing abutments following implant placement

Procedure: standard healing abutment

Interventions

customized healing abutment 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.

Customized group

standard healing abutment 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.

Standard group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of Prosthodontics, Faculty of Dentistry, Chiang Mai University

Chiang Mai, 50300, Thailand

Location

Study Officials

• Pimduen Rungsiyakull, AssocProfDr

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 9, 2023
• Study Start: June 1, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2025
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)