Digital Assessment at Peri-implant Tissues After Immediate Implants With Customized Healing Abutments and Connective Tissue Grafts

NCT05060055 | Completed

• 1 other identifier: UCatolicaPortuguesa
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

After a single-tooth extraction, physiological remodeling processes are unavoidable which leads to a total loss of the periodontal ligament and resorption of the bundle bone. Immediate implant placement associated with bone substitutes and customized healing abutments seems to reduce the amount of resorption at peri-implant areas. Recently, studies evaluating the use of a connective tissue grafts are being conducted in order to assess possible final outcome advantages in immediate implant procedures. This study aims to evaluate peri-implant tissue dimensional changes after the use of a customized healing abutment with or without connective tissue graft in flapless maxillary immediate implant placement.

Conditions

Dental Implant Failed

Keywords

autografts; wound healing; three-dimensional imaging; treatment outcome; dental implants; alveolar ridge augmentation; alveolar bone loss

Outcome Measures

Primary Outcomes (9)

• Buccal volume variation (BVvT0)

  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)

• Buccal volume variation (BVvT1)

  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.

  1 month (T1)

• Buccal volume variation (BVvT2)

  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.

  4 months (T2)

• Buccal volume variation (BVvT3)

  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.

  12 months (T3)

• Total volume variation (TVvT0)

  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)

• Total volume variation (TVvT0)

  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)

• Total volume variation (TVvT1)

  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

  1 month (T1)

• Total volume variation (TVvT2)

  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

  4 months (T2)

• Total volume variation (TVvT3)

  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

  12 months (T3)

Secondary Outcomes (1)

• Buccal wall thickness (BT)

  Baseline

Study Arms (2)

Test Group

EXPERIMENTAL

Customized healing abutment inserted in immediate implant placement in association with the use of a connective tissue graft.

Procedure: Immediate dental implant placement

Control Group

ACTIVE COMPARATOR

Customized healing abutment inserted in immediate implant placement.

Procedure: Immediate dental implant placement

Interventions

Immediate dental implant placement PROCEDURE

Immediate dental implant placement

Control Group; Test Group

Eligibility Criteria

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

You may qualify if:

• \) ≥18 years of age; 2) patients who had a failing tooth and needed an implant placing therapy in the aesthetic zone (between 15-25); 3) the failing tooth has adjacent and opposing natural teeth; 4) sufficient mesial-distal and inter-occlusal space for placement of the implant and definitive restoration; 5) had an intact socket wall previously to the extraction; 6) 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

Study Sites (1)

Universidade Católica Portuguesa

Viseu, 3500, Portugal

Location

Related Publications (1)

• Fernandes D, Marques T, Borges T, Montero J. Volumetric analysis on the use of customized healing abutments with or without connective tissue graft at flapless maxillary immediate implant placement: A randomized clinical trial. Clin Oral Implants Res. 2023 Sep;34(9):934-946. doi: 10.1111/clr.14119. Epub 2023 Jun 29.

  PMID: 37386752 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

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: Adjunct-Professor, Head of Oral Surgery, Center for Interdisciplinary Research in Health. Faculty of Dental Medicine, Universidade Católica Portuguesa, Viseu, Portugal.

Model Details: The present study was designed as a prospective, controlled clinical trial with a parallel-group design and balanced randomization (ratio 1:1)

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: September 28, 2021
• Study Start: October 1, 2021
• Primary Completion: November 4, 2022
• Study Completion: November 9, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

PT (1)