Multi-level Dimensional Changes at Immediate Implant Sites

NCT04432519 | Completed

• 1 other identifier: 06.2019
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Studies evaluating the use of customized healing screws/abutments in immediate implant placement have been performed, aiming to assess possible advantages with the use of this treatment modality. Despite the existence of these investigations, there is a lack of information regarding a digital approach to evaluate in an objective manner soft and hard tissue dimensional changes at this treatment modality.

Conditions

Dental Implant Failed

Outcome Measures

Primary Outcomes (2)

• Buccal volume variation (BVv)

  Variation of the alveolar volume at the buccal aspect. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Buccal Volume Variation (BVv0-1, BVv0-2, and BVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0.

  Baseline (T0); 1 month (T1); 4 months (T2) and 12 months (T3)

• Total volume variation (TVv)

  Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0

  Baseline (T0); 1 month (T1); 4 months (T2) and 12 months (T3)

Secondary Outcomes (1)

• Buccal wall thickness (BT)

  baseline

Study Arms (2)

Group CA

EXPERIMENTAL

Customized healing abutment inserted in immediate implant placement.

Procedure: Immediate dental implant placement

Group CM

ACTIVE COMPARATOR

Resorbable Collagen Membrane for socket closure in immediate implant placement.

Procedure: Immediate dental implant placement

Interventions

Immediate dental implant placement PROCEDURE

Dental implant insertion in the same surgical stage of the tooth extraction, consisting in implant placement in the fresh socket.

Also known as: Post extraction immediate implant placement

Group CA; Group CM

Eligibility Criteria

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

You may qualify if:

• patients with ≥18 years of age;
• patients who had a failing tooth and needed an implant placing therapy in the aesthetic zone (between 15-25);
• the failing tooth has adjacent and opposing natural teeth;
• sufficient mesial-distal and inter-occlusal space for placement of the implant and definitive restoration;
• had an intact socket wall previously to the extraction;
• had sufficient apical bone to place an immediate implant with minimum primary stability of 30 N/cm.

You may not qualify if:

• individuals diagnosed with periodontal disease;
• medical and general contraindications for the surgical procedure;
• heavy smokers (\> 10 cigarettes/day); .an active infection at the implant site.

Sponsors & Collaborators

• Universidade Católica Portuguesa: lead
• Danilo Fernandes: collaborator

Study Sites (1)

Universidade Católica Portuguesa /FMD

Viseu, 3504-505, Portugal

Location

Study Design

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

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: June 1, 2019
• Primary Completion: June 8, 2020
• Study Completion: June 8, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

PT (1)