NCT04299750

Brief Summary

The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.

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
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

May 3, 2015

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

3.1 years

First QC Date

May 3, 2015

Last Update Submit

March 4, 2020

Conditions

Tooth Avulsion

Keywords

Socket preservationSingle implantTooth extraction

Outcome Measures

Primary Outcomes (1)

  • Number of implants ideally placed

    The main goal is to determine if alveolar ridge preservation affects optimal implant positioning. This is defined as the implant position allowing to fulfill the ideal prosthetic design of the crown to be restored.

    6 months

Secondary Outcomes (2)

  • Peri-implant bone variation

    6 months

  • Ridge volume at 6 months after tooth extraction

    6 months

Study Arms (2)

Alveolar Ridge Preservation

EXPERIMENTAL

Patients in this arm will undergo atraumatic extraction of an hopeless tooth and a socket preservation procedure. Alveolar ridge preservation will be performed using a slow-resorption bone substitute and a collagen membrane that covers the graft.

Procedure: Tooth extraction and Alveolar ridge preservation

Natural healing

ACTIVE COMPARATOR

Patients in this arm will undergo atraumatic extraction of an hopeless tooth. The socket will follow natural healing.

Procedure: Tooth extraction

Interventions

Tooth extraction and Alveolar ridge preservationPROCEDURE

Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal

Also known as: Socket preservation
Alveolar Ridge Preservation
Tooth extractionPROCEDURE

Tooth extraction and socket natural healing

Also known as: Socket natural healing
Natural healing

Eligibility Criteria

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

You may qualify if:

  • at least 18 years of age
  • at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession;
  • adequate oral hygiene, i.e. plaque index score ≤10%;
  • mesial-distal width of inter-dental space ≥7 mm;

You may not qualify if:

  • American Society of Anesthesiologists (ASA) score ≥III
  • presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing
  • a history of radiotherapy to the head and neck region
  • presence of conditions requiring chronic use of antibiotics
  • medical conditions requiring prolonged use of steroids
  • history of leucocyte dysfunction
  • history of bleeding disorders
  • history of renal failure
  • patients with metabolic bone disorders
  • patients with uncontrolled endocrine disorders
  • disability affecting oral hygiene
  • alcohol or drug abuse
  • HIV infection
  • smoking \>10 cigarettes a day or cigar equivalents
  • conditions or circumstances that would prevent completion of study participation
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitario di Odontoiatria

Parma, PR, 43126, Italy

Location

MeSH Terms

Conditions

Tooth Avulsion

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Tooth InjuriesTooth DiseasesStomatognathic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Guido Macaluso, MDS, MSc

    University of Parma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DDS, PhD, MSc

Study Record Dates

First Submitted

May 3, 2015

First Posted

March 9, 2020

Study Start

October 1, 2016

Primary Completion

November 1, 2019

Study Completion

July 1, 2020

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

IT(1)