Clinical trial NCT05235048: Single Tooth Extraction in Damaged Alveoli and Implant Site Development:TootToo
Official title: Single Tooth Extraction in Damaged Alveoli and Implant Site Development Randomized Controlled Clinical Trial Comparing Socket Preservation and Reconstruction Surgery to Spontaneous Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction Status Nos
Keywords: Alveolar ridge preservation
Tooth extraction
Dental implant
Lead sponsor: The European Research Group on Periodontology (ERGOPerio)
Sponsor class: NETWORK
Collaborators: name: The University of Hong Kong
First posted: 2022-02-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a parallel group, standard of care-controlled, assessor-blind, randomized, multicenter, superiority clinical trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Possibility to place dental implant
timeFrame: 16-20 weeks
measure: Surgeon's confirmation of the ability to place a dental implant
timeFrame: 16-20 weeks
Secondary outcomes:
measure: Vertical change in bone height at the deepest point in the socket
timeFrame: 16-20 weeks
measure: Vertical change in bone height at the buccal bone crest
timeFrame: 16-20 weeks
measure: Vertical change in bone height at the crest of adjacent teeth
timeFrame: 16-20 weeks
measure: Radiographic bone changes
timeFrame: 16-20 weeks
measure: Change in keratinized tissue width between baseline and insertion of prosthetic crown
timeFrame: 16-20 weeks
measure: Need for additional bone augmentation at the time of implant placement (and/or implant uncovering, if submerged healing)
timeFrame: 16-20 weeks
measure: Wound healing index
timeFrame: 1-4 weeks
measure: OHIP-14
timeFrame: 1-2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Investigator
name: Pierpaolo Cortellini, MD
role: STUDY_DIRECTOR
References: