NCT03548896

Brief Summary

There is limited data regarding socket preservation in three wall defects and no enough evidence of implant placement in previously regenerated area with allograft. The aim of this randomized controlled clinical trial is to analyze and compare dimensional changes in extractions sites with buccal bone defects \> 5 mm left untreated (simultaneous regeneration during implant placement) or treated using a mineralized allograft.

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

2.8 years

First QC Date

January 28, 2018

Last Update Submit

July 6, 2018

Conditions

Dental ImplantSocket Preservation

Keywords

implant

Outcome Measures

Primary Outcomes (1)

  • total width of the buccolingual bone

    to evaluate the bone changes in cone beam computed tomography

    Baseline, 3 months, 1 year

Secondary Outcomes (5)

  • keratinized tissue

    Baseline, 3 months and at 1 year

  • soft tissue level

    Baseline, 3 months and at 1 year

  • pink esthetic score

    Baseline, 3 months and at 1 year

  • volumetric soft tissue changes (linear measurement)

    At 3 months and at 1 year

  • radiographic bone loss (in millimeters)

    At 3 months, and at 1 year

Study Arms (3)

Dental Implants

EXPERIMENTAL

Dental implants Titanium SLA treated surface of different dimensions according to the specific needs of the patient

Procedure: Post extraction socket

Resorbable membrane

EXPERIMENTAL

Resorbable membrane Cross link collagen membrane from porcine animal with a measure of 15 x 25 mm

Procedure: Post extraction socket

Allograft

EXPERIMENTAL

Allograft Bone from human source that is administered in a dosage of 1 cc per patient

Procedure: Post extraction socket

Interventions

Post extraction socketPROCEDURE

\*\*Dental implant will be placed 3 months after tooth extraction

AllograftDental ImplantsResorbable membrane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over 18 years old.
  • Patients requiring single tooth extraction with partial or total absence of the buccal bone wall that will be defined as loss of more than 5 mm with respect to the supposed location of the bone crest (23).
  • Presence of adjacent teeth.
  • Anterior teeth (from second premolar to second premolar) of the maxilla.
  • Patients who had requested an implant restoration between adjacent teeth
  • Absence of active periodontal disease.
  • Good level of oral hygiene (Plaque Index \< 25%; (27).
  • Absence of systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes mellitus, osteoporosis, biphosphonate medication).
  • Non-smokers or light smokers (\< 10 cigarettes per day).
  • Written informed consent signed.

You may not qualify if:

  • Buccal soft tissue recession.
  • Acute infection at the extraction site.
  • Presence of adjacent implants.
  • Absence of any adjacent tooth
  • Long-term non-steroidal anti-inflammatory drug therapy (3 months).
  • Lactating females or currently pregnancy.
  • Severe cognitive or psychiatric disorders.
  • Unwillingness to return for follow-up examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, Catalonia, 08017, Spain

RECRUITING

Study Officials

  • PEDRO DIZ

    Universitat Internacional de Catalunya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DIZ

CONTACT

+34 630793155PEDRODIZIGLESIAS@GMAIL.COM

DIZ

CONTACT

630793155

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 28, 2018

First Posted

June 7, 2018

Study Start

February 1, 2016

Primary Completion

November 1, 2018

Study Completion

July 1, 2019

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

ES(1)