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Completed

NCT Number: NCT05235048

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

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?

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Key information

Conditions

Tooth Extraction Status Nos

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tooth extraction

Procedure

Atraumatic tooth extraction without flap elevation

Tooth extraction and socket seal with connective tissue graft

Procedure

Atraumatic tooth extraction without flap elevation and seal of the alveolar socket with connective tissue graft (microsurgery)

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

Procedure

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)

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

Procedure

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)

Primary outcomes

  1. Possibility to place dental implant

    Time frame: 16-20 weeks

    The possibility to place a dental implant in a prosthetically driven position (with or without bone or soft tissue augmentation) 16-20 weeks after tooth extraction will be evaluated with a dedicated planning software using cone beam CT data and and digital scanning according to standard clinical practice

  2. Surgeon's confirmation of the ability to place a dental implant

    Time frame: 16-20 weeks

    Confirmation during the surgery of the ability to actually insert the implant in a prosthetically driven position with or without the need for soft or hard-tissue augmentation.

Secondary outcomes

  1. Vertical change in bone height at the deepest point in the socket

    Time frame: 16-20 weeks

    Bone fill of the socket evaluated at the time of dental implant placement as change in the distance between a customized surgical stent and the bottom of the alveolus using a periodontal probe (difference between baseline and 16-20 week healing)

  2. Vertical change in bone height at the buccal bone crest

    Time frame: 16-20 weeks

    Bone fill of the socket evaluated at the time of dental implant placement as change in the distance between a customized surgical stent and the bottom of the alveolus using a periodontal probe (difference between baseline and 16-20 week healing)

  3. Vertical change in bone height at the crest of adjacent teeth

    Time frame: 16-20 weeks

    Harm to bone of adjacent teeth measured by clinical attachment level loss and trans gingival probing.

  4. Radiographic bone changes

    Time frame: 16-20 weeks

    Bone fill of the socket measured on routine intraoral radiographs

  5. Change in keratinized tissue width between baseline and insertion of prosthetic crown

    Time frame: 16-20 weeks

    Soft tissue preservation assessed as millimetre of keratinised tissue as measured with a periodontal probe

  6. Need for additional bone augmentation at the time of implant placement (and/or implant uncovering, if submerged healing)

    Time frame: 16-20 weeks

    Need for additional augmentation assessed by the surgeon during implant placement

  7. Wound healing index

    Time frame: 1-4 weeks

    Early healing assessed with standardized composite healing index by dentist

  8. OHIP-14

    Time frame: 1-2 weeks

    Oral health related quality of life standard instrument (questionnaire) - 5 point Likert scale with greater scores indicating better quality of life.

Sponsors and collaborators

Lead sponsor

The European Research Group on Periodontology (ERGOPerio)

Network

Collaborators

  • The University of Hong Kong

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2022
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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