Impact of Transepithelial Abutment Connection and Disconnection in Dental Implants

Last updated: October 10, 2024
Sponsor: University of Valencia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Periodontitis

Bone Density

Treatment

Ti-base placement

abutment placement

Clinical Study ID

NCT06629961
3395885
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy partially edentulous adult patients needing at least two implants for theplacement of single or consecutive crowns in the posterior mandible or maxilla willbe recruited.

  • These patients should exhibit a plaque index and gingival bleeding index of lessthan 25%, and have sufficient bone height and width for the placement of dentalimplants measuring 8 or 10 mm in length and 3.5 or 4 mm in diameter.

  • Additionally, they must have at least 2 mm of keratinized vestibular gingiva, stableocclusion, and a periodontium in good health

Exclusion

Exclusion Criteria:

  • Edentulous areas requiring bone grafts will be excluded.

  • Patients with medical conditions contraindicating implant surgery, such as severebruxism or inadequate oral hygiene.

  • Pregnant or lactating women, patients undergoing bisphosphonate therapy, thosereceiving chemotherapy or radiotherapy in the head and neck area, non-compliantpatients with incomplete data records, and those who do not attend regular follow-upappointments will also be excluded.

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Ti-base placement
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
November 01, 2025

Connect with a study center

  • Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

    Valencia, 46010
    Spain

    Completed

  • Facultad de Medicina y Odontología de la Universitat de València

    Valencia, 46010
    Spain

    Active - Recruiting

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