NCT04705181

Brief Summary

The aim of the present study is to investigate whether there has been a change of criteria for tooth extraction at Tufts University School of Dental Medicine (TUSDM) from 2005 to 2018. The primary outcome is the change of mean of radiographic interproximal bone loss of extracted teeth. The secondary outcomes are changes of other parameters (periodontal, endodontic and restorative) of extracted teeth and reasons for extraction.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Mar 2020Jun 2028

Study Start

First participant enrolled

March 19, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

7.3 years

First QC Date

January 8, 2021

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Part 1: Change in mean of radiographic interproximal bone loss of extracted teeth

    * All the measurements are based on the following reference points projected onto the theoretical tooth long axis * Cemento-enamel junction (CEJ); if there is dental restoration or prosthesis on tooth making CEJ undetectable on the radiographs, the apical margin of dental restoration or prosthesis will be used as CEJ * The most apical points of mesial and distal interproximal bone height * The apex of root * The radiographic mesial and distal bone loss will be determined by the proportion of the distance between bone height to apex and the distance between CEJ to apex, projected on the tooth axis * The greater bone loss of the mesial and distal sides on radiographs will be used for further analysis

    2005-2018

  • Part 2: Change of criteria for tooth extraction

    The aim for sub-project 2 represent an extension of the Aim for Subproject 1 outlined above. This sub-project will investigate whether there has been a change of criteria for tooth extraction at TUSDM from 2007 to 2018 specifically for and limited to molar teeth that were extracted and subsequently replaced with dental implants. Criteria for extraction of first molar teeth has changed between 2007 and 2018 toward early extraction of teeth with less severe periodontal and other conditions.

    2007-2018

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had fully-erupted first molar extraction (tooth number #3 or #14 or #19 or #30) under CDT code of D7140 (Extraction, erupted tooth or exposed root) and D7210 (Extraction, erupted tooth requiring removal of bone and/or sectioning of tooth, and including elevation of mucoperiosteal flap if indicated) at TUSDM

You may qualify if:

  • Patients who had fully-erupted first molar extraction (tooth number #3 or #14 or #19 or #30) under Code on Dental Procedures and Nomenclature (CDT) code of D7140 (Extraction, erupted tooth or exposed root) and D7210 (Extraction, erupted tooth requiring removal of bone and/or sectioning of tooth, and including elevation of mucoperiosteal flap if indicated) at TUSDM.
  • The electronic records must include the following data:
  • Gender
  • Age
  • Comprehensive periodontal chart, including probing depth (PD), clinical attachment level (CAL), furcation involvement and mobility. The periodontal chart has to be recorded within 12 months before tooth extraction
  • Periapical radiograph and bite-wing radiographs of extracted tooth. The radiographs have to be taken within 12 months before tooth extraction
  • Reasons for tooth extraction
  • Part 2:
  • Patients who had:
  • Fully-erupted first and second molars (tooth number #2, #3, #14, #15, #18, #19, #30, #31) that were extracted under CDT codes D7140 (Extraction, erupted tooth or exposed root) or D7210 (Extraction, erupted tooth requiring removal of bone and/or sectioning of tooth, and including elevation of mucoperiosteal flap if indicated).
  • The same extracted tooth were replace with dental implant placement under CDT code D6010 (Surgical placement, endosteal implant) within 24 months after extraction.
  • The electronic records must include the following data
  • Sex
  • Age
  • Dental records including:
  • +1 more criteria

You may not qualify if:

  • Absence of tooth distal to extracted tooth.
  • a. Clinical decision for tooth extraction may be affected by tooth location. When the tooth is the distal abutment in the dentition, clinicians tend to keep the tooth even if the prognosis is compromised.
  • Presence of dental implant adjacent to extracted tooth a. Clinical decision for tooth extraction may be affected by adjacent dental implants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Study Officials

  • Bjorn Steffensen, DDS, MS, PhD

    Tufts University School of Dental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair Department of Periodontology

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 12, 2021

Study Start

March 19, 2020

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations