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Impact of Transepithelial Abutment Connection and Disconnection in Dental Implants

NCT06629961 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-10-15

No results posted yet for this study

Summary

Over the past decade, implant research has focused on maintaining the health and stability of peri-implant tissues. A key factor is platform switching at the bone level, where a narrower abutment than the implant is used. This technique increases the implant's horizontal surface area for biological width establishment and reduces stress on the crestal bone.

Studies showed that repeated disconnection and reconnection of prosthetic components could compromise the mucosal barrier around implants, leading to an apical shift in the connective tissue junction and vertical tissue loss. This led to the "one abutment, one time" protocol, advocating the placement of the definitive abutment during initial implant surgery to avoid its removal during healing.

A recent meta-analysis indicated bone loss at the marginal level due to abutment connection and disconnection, despite different treatment protocols. Thus, a standardized abutment between the fixed prosthesis and the implant has been recommended to preserve marginal bone levels. This approach moves the biological width apically, protecting the bone from irritation and improving marginal bone isolation.

However, comparative evidence between direct implant-connected prostheses and trans-epithelial abutments is lacking. This study aims to evaluate the "one abutment, one time" protocol's effect on bone loss 12 months after prosthesis placement.

Secondary objectives include assessing patient satisfaction using Patient-Reported Outcome Measures (PROM) during prosthesis fabrication and placement, and obtaining information on the diversity and function of microorganisms on the implant using metagenomic techniques 12 months post-prosthesis placement.

Throughout the prosthesis fabrication and the first 12 months, various evaluations will be conducted in both abutment and Ti-base groups:

* \*\*Bleeding:\*\* Recorded during various prosthetic stages.
* \*\*Pain:\*\* Assessed using a visual analog scale after each stage.
* \*\*Anesthesia:\*\* Recorded if used at each stage.
* \*\*Radiographs:\*\* Number taken to check the fit.
* \*\*Time:\*\* Measured for each prosthetic phase.
* \*\*Repetitions:\*\* Number of repeated procedures quantified.
* \*\*Metagenomic tests:\*\* Samples collected following the Human Microbiome Project protocol to analyze microbial diversity and function.

Conditions

  • Bone Loss
  • Bacterium; Agent
  • Satisfaction, Patient

Interventions

PROCEDURE

abutment placement

Placement of a subcrestal implant at more than 35 N and placement of a trans-epithelial abutment at 30 N

PROCEDURE

Ti-base placement

Placement of a subcrestal implant at more than 35 N and placement of a Tibase placement at 30 N

Sponsors & Collaborators

  • University of Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-11-01
Completion
2025-11-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06629961 on ClinicalTrials.gov