NCT05235048

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

Single Tooth Extraction in Damaged Alveoli and Implant Site Development Randomized Controlled Clinical Trial Comparing Socket Preservation and Reconstruction Surgery to Spontaneous Healing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: The European Research Group on Periodontology (ERGOPerio) · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed 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.

Conditions

• Tooth Extraction Status Nos

Interventions

Type	Name	Description
PROCEDURE	Tooth extraction	Atraumatic tooth extraction without flap elevation
PROCEDURE	Tooth extraction and socket seal with connective tissue graft	Atraumatic tooth extraction without flap elevation and seal of the alveolar socket with connective tissue graft (microsurgery)
PROCEDURE	Tooth extraction and socket seal with BRG and connective tissue graft and	Atraumatic tooth extraction without flap elevation, position of a bone replacement graft into the socket and seal of the alveolar socket with connective tissue graft (microsurgery)
PROCEDURE	Tooth extraction and socket seal with membrane placement, BRG and connective tissue graft	Atraumatic tooth extraction without flap elevation, position of a collagen membrane and bone replacement graft into the socket and seal of the alveolar socket with connective tissue graft (microsurgery)

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2022-02-10
• Last updated: 2022-04-01