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

Tooth Extraction Status Nos Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235048
• Other study ID #: ERGOPerio 15-01
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: September 2017

Study information

• Verified date: March 2022
• Source: The European Research Group on Periodontology (ERGOPerio)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Extraction Status Nos

Intervention

Procedure:
• Tooth extraction
Atraumatic tooth extraction without flap elevation
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The European Research Group on Periodontology (ERGOPerio)	The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Possibility to place dental implant	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	16-20 weeks
Primary	Surgeon's confirmation of the ability to place a dental implant	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.	16-20 weeks
Secondary	Vertical change in bone height at the deepest point in the socket	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)	16-20 weeks
Secondary	Vertical change in bone height at the buccal bone crest	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)	16-20 weeks
Secondary	Vertical change in bone height at the crest of adjacent teeth	Harm to bone of adjacent teeth measured by clinical attachment level loss and trans gingival probing.	16-20 weeks
Secondary	Radiographic bone changes	Bone fill of the socket measured on routine intraoral radiographs	16-20 weeks
Secondary	Change in keratinized tissue width between baseline and insertion of prosthetic crown	Soft tissue preservation assessed as millimetre of keratinised tissue as measured with a periodontal probe	16-20 weeks
Secondary	Need for additional bone augmentation at the time of implant placement (and/or implant uncovering, if submerged healing)	Need for additional augmentation assessed by the surgeon during implant placement	16-20 weeks
Secondary	Wound healing index	Early healing assessed with standardized composite healing index by dentist	1-4 weeks
Secondary	OHIP-14	Oral health related quality of life standard instrument (questionnaire) - 5 point Likert scale with greater scores indicating better quality of life.	1-2 weeks