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

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340726
• Other study ID #: 02/2015
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 31, 2015

Study information

• Verified date: April 2020
• Source: Universidade Católica Portuguesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 31, 2015
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant Failed

Intervention

Procedure:
• One time abutment

Locations

Country	Name	City	State
Portugal	Universidade Católica Portuguesa	Viseu

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Católica Portuguesa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal bone changes	Crestal bone changes that occur around the dental implant	60 months