Immediate Implants: to Graft or Not to Graft, That is the Question.

NCT05927181 | Completed

• 1 other identifier: TMA-USE-001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The aim was to compare two protocols for immediate implants with fixed provisional restoration, no grafting (trimodal approach=TA) versus grafting both osseous gap and peri-implant mucosa (trimodal approach with modification of the osseous and mucosal compartments =TAOM) by measuring the soft tissue changes overtime. The periodontal phenotype was registered, to investigate a relationship between its thickness and the clinical outcomes.

Conditions

Dental Implant

Keywords

Immediate Implants; soft tissue graft; immediate implant restoration

Outcome Measures

Primary Outcomes (1)

• Distance from measuring points on the reference stent to gingival zenith of the implant restoration in tenths of a milimetre by means of a precision digital calliper.

  Vertical midfacial soft tissue change from baseline (before tooth extraction) to 12 months following implant placement.

  12 months

Secondary Outcomes (2)

• Distance from measuring points on the reference stent to mesial and distal papillae of the implant restoration in tenths of a milimetres by means of a precision digital calliper.

  12 months

• Periodontal thickness at 5mm apical to the gingival margin in tenths of a milimetre.

  Baseline

Study Arms (2)

Trimodal Approach with Osseous and Mucosal compartment modification: TAOM

EXPERIMENTAL

Flapless immediate implant placement and provisional restoration with alveolar filling and connective tissue graft.

Procedure: TAOM

Trimodal Approach: TA

ACTIVE COMPARATOR

Flapless immediate implant placement and provisional restoration.

Procedure: TAOM

Interventions

TAOM PROCEDURE

In the TAOM group, the gap between the implant and the facial bone wall was grafted with inorganic bovine bone (Geistlich Bio-Oss®; Geistlich Pharma AG, Wolhusen, Switzerland) and, in addition, a connective tissue graft (CTG) was placed submucosally on the labial bone plate by means of an envelope technique.

Also known as: Trimodal approach with osseous and mucosal interventions.

Trimodal Approach with Osseous and Mucosal compartment modification: TAOM; Trimodal Approach: TA

Eligibility Criteria

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

You may qualify if:

• Need for tooth extraction in the anterior maxilla (13-23) due to cavities, internal resorption, fractures, restorative problems, endodontic complications and prosthetic reasons.
• The failing tooth has adjacent and opposing natural teeth
• Adequate oral hygiene (Bleeding on probing \<20%; Plaque index \<20%);
• Absence of active and uncontrolled periodontal disease
• Sufficient mesial-distal and interocclusal space for implant placement and definitive restoration
• Sufficient interocclusal space to design a non-occluding provisional restoration

You may not qualify if:

• Systemic metabolic or osseous disease that could compromise peri-implant tissue healing.
• Acute infection in the treatment area
• Absence of one or both adjacent teeth
• Non-integrity of the buccal bone wall (dehiscence or fenestration) observed during surgery, or when tooth extraction has altered the integrity of the osseous and gingival architecture

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Maria Del Rosario Rioboo Crespo

Madrid, 28003, Spain

Location

Study Officials

• Gustavo G Cabello

  Private Practice, Málaga, Spain

  PRINCIPAL INVESTIGATOR

• Javier J Fabrega

  Private Practice, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: July 3, 2023
• Study Start: April 1, 2009
• Primary Completion: March 1, 2016
• Study Completion: February 1, 2020
• Last Updated: July 3, 2023

Record last verified: 2023-05

Locations

ES (1)