Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas

Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas: Results From a Randomized Prospective Clinical Trial

The aim of this study was to compare the influence of the abutment height and insertion timing on early marginal bone loss (MBL) in posterior mandibular partial implant-supported restorations.

Material and methods: The study was planned as a prospective, randomized, controlled parallel group including subjects in need of two implants for the restoration of an edentulous posterior mandibular area. Data were gathered on age, gender, attached gingiva height, bleeding on probing (BoP), smoking habits and previous periodontitis. The patients were allocated into three groups: Group A implants were immediately connected to 2 mm height abutments; Group B implants were immediately connected to 1 mm height abutments; Group C implants were left to heal in a sub-mucosal position and 2 mm abutments were inserted in a second stage surgery. Peri-apical radiographs were taken at the implant surgery (baseline), 4 weeks after surgery (T1), 16 weeks after implant placement at the final restoration delivery (T2) and 1-year after implant placement (T3).

Study Overview

• Status: Completed
• Conditions: Dental Implant Failed
• Intervention / Treatment: Procedure: One time abutment

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Viseu, Portugal, 3500
    • Universidade Católica Portuguesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients age > 18 years;
• American Society of Anaesthesiologists (ASA) status I;
• no systemic medication or condition known to potentially alter bone metabolism; - absense of acute periodontal condition.

Exclusion Criteria:

• lack of primary stability at implant surgery;
• need for bone regeneration procedures during surgery;
• inability to correct place the implant in accordance with the prosthetic requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone changes	Crestal bone changes that occur around the dental implant	60 months

Collaborators and Investigators

• Sponsor: Universidade Católica Portuguesa

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 02/2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No