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

NCT04340726 | Completed

• 1 other identifier: 02/2015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dental Implant Failed

Outcome Measures

Primary Outcomes (1)

• Marginal bone changes

  Crestal bone changes that occur around the dental implant

  60 months

Interventions

One time abutment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Católica Portuguesa: lead

Study Sites (1)

Universidade Católica Portuguesa

Viseu, 3500, Portugal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 9, 2020
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 31, 2015
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

PT (1)