Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06629961

Impact of Transepithelial Abutment Connection and Disconnection in Dental Implants

Led by University of Valencia · Updated on 2024-10-15

32

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Impact of Transepithelial Abutment Connection and Disconnection in Dental Implants

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults needing at least two implants for single or consecutive crowns in the back of the upper or lower jaw
  • Plaque index and gingival bleeding index less than 25%
  • Sufficient bone height and width for dental implants of 8 or 10 mm length and 3.5 or 4 mm diameter
  • At least 2 mm of keratinized vestibular gingiva
  • Stable bite and healthy periodontium
Not Eligible

You will not qualify if you...

  • Edentulous areas requiring bone grafts
  • Medical conditions that prevent implant surgery, such as severe teeth grinding or poor oral hygiene
  • Pregnant or breastfeeding women
  • Patients receiving bisphosphonate therapy
  • Patients undergoing chemotherapy or radiotherapy in the head and neck region
  • Patients who do not comply or have incomplete data records
  • Patients not attending regular follow-up visits

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, Spain, 46010

Completed

2

Facultad de Medicina y Odontología de la Universitat de València

Valencia, Spain, 46010

Actively Recruiting

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Research Team

D

DAVID PEÑARROCHA, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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