NCT04534361

Brief Summary

The scientific evidence available at present regarding the alterations suffered by the alveolar ridge after the explantation of implants that have been considered to be abandoned due to periimplantitis, as well as the remaining sequelae from said treatment, is scarce and inconclusive. Regarding this background, it is speculated that the different types of peri-implant defects present different bone remodeling and different sequelae after the explantation of the implants affected by peri-implantitis. Thus, it has been hypothesized that the peri-implant defect configuration has an influence on the radiographic bone alterations that occur after explantation. In order to test this hypothesis, a retrospective study has been designed as it follows: Patients who have undergone implant placement procedure and suffer from peri-implantitis will be consecutively included in the study. In addition, patients should present at least 2 CBCTs taken before and after explantation, 4-6 months apart. Linear measurements will be taken in order to assess dimensional changes of the alveolar ridge at 1, 3, 5 and 7 mm from the bone crest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 15, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

15 days

First QC Date

August 26, 2020

Last Update Submit

November 11, 2021

Conditions

Keywords

dental implantdental implant failureperi-implantitisbone lossbone remodelingimplant explantation

Outcome Measures

Primary Outcomes (1)

  • bone level changes

    bone level changes (mm) and peri-implant defect morphology alterations after implant explantation

    4-6 months after implant explantation

Interventions

No intervention will be performed on patients for this study. Based on the CBCTs already done previously of the patients in the sample, linear measurements will be taken in order to assess dimensional changes of the alveolar ridge at 1, 3, 5 and 7 mm from the bone crest in the CBCTs taken before and after implant explantation, 4-6 months apart.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient recruitment will be obtained from a private practice exclusively dedicated to periodontics and implantology (Clinica CICOM, Badajoz, Spain). Edentulous patients, either total or partial, who previously underwent implant placement procedure and which suffer severe peri-implantitis will be consecutively included in the study.

You may qualify if:

  • patients aged 18-80 years
  • patients with partial or complete edentulism with ≥1 missing teeth restored with implant-supported restorations
  • patients with implants which had been in function for a minimum of 36 months after final prosthesis delivery
  • patients presenting implant explantation due to peri-implantitis

You may not qualify if:

  • pregnancy or lactation patients
  • patients treated by zygomatic or pterygoid implants
  • patients under intake of medications known to modify bone metabolism
  • patients with uncontrolled systemic diseases (ie: diabetes mellitus)
  • patients with active periodontal disease that required treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Related Publications (1)

  • Pons R, Carreno M, Amerio E, Gargallo-Albiol J, Nart J, Monje A. Hard tissue dimensional changes following implant removal due to peri-implantitis: A retrospective study. Clin Implant Dent Relat Res. 2021 Jun;23(3):432-443. doi: 10.1111/cid.13004. Epub 2021 May 4.

MeSH Terms

Conditions

Peri-ImplantitisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jose Nart

    Universitat Internacional de Catalunya

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentistry, Master in Periodontics and Implants

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 1, 2020

Study Start

August 15, 2020

Primary Completion

August 30, 2020

Study Completion

September 1, 2020

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations