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Implant Abutment Dis-/Reconnection and Peri-Implant Marginal Bone Loss.

NCT02617212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-05-13

No results posted yet for this study

Summary

The purpose of this study is to investigate whether the immediate definitive abutment connection to dental implant is effective in preventing marginal bone loss when compared to the conventional treatment with late abutment/implant connection, which include three disconnections and reconnections.

Conditions

  • Alveolar Bone Loss

Interventions

PROCEDURE

Implant surgery

The volunteers will receive one or two dental implant(s) placed by a surgical procedure, under local anesthesia and careful soft and hard tissue handling. After implant insertion, the volunteers will be randomly assigned to one arm.

DEVICE

Three abutment dis-/reconnections.

At the active comparator arm, each implant will receive a titanium healing abutment during the surgery, according to manufacturer's recommendations. Three dis-/reconnections of abutments will be performed after the soft tissue healing period: the first, after 8 weeks, for adjustment of the emergence profile by healing abutment changing; the second, 10 weeks after surgery, for intra-oral prosthetic abutment selection; and the third, 12 weeks after surgery, for the prosthetic abutment definitive connection with the manufacturer recommended torque.

DEVICE

No abutment dis-/reconnections.

Each experimental arm implant will receive its definitive prosthetic abutment at the surgical procedure. The manufacturer recommended torque will be applied so that no disconnection of the abutment will occur during and after completion of the treatment. The abutment will receive healing caps, which shall remain in position until the end of 12 weeks after surgery.

Sponsors & Collaborators

  • Universidade Federal do Ceara

    collaborator OTHER

  • Fortaleza University

    lead OTHER

Principal Investigators

  • Rodrigo O. Rego, PhD · Universidade Federal do Ceara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Brazil

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 NCT02617212 on ClinicalTrials.gov