Single Tooth Extraction in Damaged Alveoli and Implant Site Development:TootToo

The European Research Group on Periodontology (ERGOPerio)

Status: Completed

Conditions: Tooth Extraction Status Nos

Treatments: Procedure: Tooth extraction and socket seal with membrane placement, BRG and connective tissue graft; Procedure: Tooth extraction; Procedure: Tooth extraction and socket seal with BRG and connective tissue graft and; Procedure: Tooth extraction and socket seal with connective tissue graft

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05235048

ERGOPerio 15-01

Details and patient eligibility

About

It is unclear what is the best approach to implant site development after tooth extraction when the pathology leading to extraction has damaged the alveolus. The main objective of this study is to assess if socket preservation and/or reconstruction surgery provides a clinical benefit in terms of ability to place an implant in a prosthetically guided position in such clinical conditions.

The PICO question therefore is:

In patients requiring single tooth extraction what is the benefit of socket preservation/reconstruction surgery with respect to spontaneous healing in terms of feasibility and ease of implant surgery?

Full description

This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, clinical trial.

The statistical design will be a superiority trial in terms of the primary outcome with reference to the standard of care control (spontaneous healing).

Primary outcome:

Possibility to place an implant in a prosthetically driven position with or without bone or soft tissue augmentation 16-20 weeks after tooth extraction, evaluated at planning with cone beam CT and confirmed at surgery.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Systemically healthy. No contraindications to elective oral surgery
• All pathologies requiring single tooth extraction with adjacent teeth (or implant) with the presence of at least one third of the alveolus.
• Evidence of subject ability to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS<25% and FMBS<25%)
• Ability to understand study procedures and to comply with them for the entire length of the study. Ability and willingness to give informed consent.

Exclusion criteria

• Presence of frank purulence or acute abscess at the time of extraction
• Presence of bone resorption of one or more walls of the alveolus extending to the apical third of the socket
• Self reported current smoking exceeding 20 cigarettes/day or pipe or cigar smoking
• Presence of medical contraindications to elective surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups, including a placebo group

Standard of care control

Placebo Comparator group

Description:

Tooth extraction and spontaneous healing

Treatment:

Procedure: Tooth extraction

Socket seal with CT graft

Experimental group

Description:

Tooth extraction and socket sealing with autologous connective tissue graft

Treatment:

Procedure: Tooth extraction

Procedure: Tooth extraction and socket seal with connective tissue graft

Socket seal with CT graft and bone replacement graft

Experimental group

Description:

Tooth extraction and socket sealing with autologous connective tissue graft and positioning of bone replacement graft in coronal portion of the socket

Treatment:

Procedure: Tooth extraction

Procedure: Tooth extraction and socket seal with BRG and connective tissue graft and

Procedure: Tooth extraction and socket seal with connective tissue graft

Tooth extraction and socket sealing and BRG with membrane

Experimental group

Description:

Tooth extraction and socket sealing with autologous connective tissue graft and positioning of bone replacement graft in coronal portion of the socket and positioning of collagen membrane

Treatment:

Procedure: Tooth extraction and socket seal with membrane placement, BRG and connective tissue graft

Procedure: Tooth extraction

Procedure: Tooth extraction and socket seal with BRG and connective tissue graft and

Procedure: Tooth extraction and socket seal with connective tissue graft