NCT01963884

Brief Summary

In patients that are going to be subjected to a tooth extraction in the anterior maxillary (from canine to canine) does the position of the intact alveolar socket related to maxillary basal bone interferes with the rate of resorption and remodeling process of the alveolar ridge ?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

2 years

First QC Date

October 12, 2013

Last Update Submit

October 12, 2013

Conditions

Loss of Teeth Due to ExtractionAlveolar Bone LossBone Resorption

Keywords

Extraction SocketsRidge dimensionsDental Alveolar AnatomyDental ImplantsBone Physiology

Outcome Measures

Primary Outcomes (1)

  • Changes in alveolar ridge dimensions

    report the change in alveolar extraction socket dimensions from tooth extraction to 1 year, measured in digital computer, from Cone-Beam originated images.

    From Tooth extraction (baseline T0) to T1 (6 month) to T2 (12 month)

Study Arms (3)

Alveolar Socket Below Basal Bone

Tooth and the alveolar socket are positioned below basal bone. Measure Alveolar Socket remodeling, after Tooth Extraction with cone-beam technology evaluation

Procedure: Tooth ExtractionRadiation: Cone-Beam technology evaluationOther: Measure Alveolar Socket Remodeling

Alveolar Socket in Basal Bone (imbedded)

Tooth and alveolar socket are positioned in basal bone. Measure Alveolar Socket remodeling, after Tooth Extraction with cone-beam technology evaluation

Procedure: Tooth ExtractionRadiation: Cone-Beam technology evaluationOther: Measure Alveolar Socket Remodeling

Alveolar Socket Buccal to Basal Bone

Tooth and alveolar socket are positioned buccally in relation to maxillary basal bone. Measure Alveolar Socket remodeling, after Tooth Extraction with cone-beam technology evaluation

Procedure: Tooth ExtractionRadiation: Cone-Beam technology evaluationOther: Measure Alveolar Socket Remodeling

Interventions

Tooth ExtractionPROCEDURE

Tooth from the maxillary anterior area extracted and alveolar socket remains intact

Alveolar Socket Below Basal BoneAlveolar Socket Buccal to Basal BoneAlveolar Socket in Basal Bone (imbedded)
Cone-Beam technology evaluationRADIATION

Patient is submitted to a localized cone-beam image before tooth extraction and 6 month later, prior to implant installation.

Also known as: Computerized Tomography, Imaging exams
Alveolar Socket Below Basal BoneAlveolar Socket Buccal to Basal BoneAlveolar Socket in Basal Bone (imbedded)
Measure Alveolar Socket RemodelingOTHER

In a computer, cone-beam images are superimposed to measure total the amount of ridge dimension

Also known as: Digital Measurements
Alveolar Socket Below Basal BoneAlveolar Socket Buccal to Basal BoneAlveolar Socket in Basal Bone (imbedded)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that require at least on tooth extraction of the upper anterior jaw (maxilla) canine, central incisor and lateral incisor.

You may qualify if:

  • Patient that require a maxillary anterior extraction
  • Sign Informed Consent
  • Indication for a two-stage implant placement

You may not qualify if:

  • Indication for immediate implants
  • Indication for alveolar socket preservation or bone regeneration
  • Indication for soft tissue graft
  • Diabetes
  • taking oral or intravenous biphosphonates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Implantologia

Lisbon, Lisbon District, 1500-662, Portugal

Location

MeSH Terms

Conditions

Alveolar Bone LossBone Resorption

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Andre Chen, Msc

    Implantology Institute

    PRINCIPAL INVESTIGATOR

  • João Caramês, Phd

    Implantology Institute

    STUDY DIRECTOR

  • Helena Francisco, Msc

    Implantology Institute

    STUDY CHAIR

  • Elena Cervino, Msc

    Implantology Institute

    STUDY CHAIR

Central Study Contacts

André Chen, Msc

CONTACT

00351919774343tsouchen@gmail.com

Elena Cervino, Msc

CONTACT

00351919074338elecer@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

October 12, 2013

First Posted

October 16, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

August 1, 2016

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

PT(1)