NCT04980313

Brief Summary

The present clinical trial will try to demonstrate the efficacy of stable xenogeneic collagen matrix in maintaining the vestibular coronal soft tissue volume and the stabilization of mid-buccal margin position in immediate post-extraccion sockets compared with the use of autogenous connective tissue grafts.

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
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration 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

April 27, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

June 29, 2021

Last Update Submit

July 18, 2021

Conditions

Xenograft Model

Keywords

immediate dental implantsdental extractionalveolar socketconnective tissue graftxenogenic collagen matrix

Outcome Measures

Primary Outcomes (3)

  • Analyze the volumetric dimensional changes between the test and the control group

    Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.

    At T0(initial) before extraction

  • Analyze the volumetric dimensional changes between the test and the control group

    Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.

    At T6 (6 months after extraction)

  • Analyze the volumetric dimensional changes between the test and the control group

    Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.

    At T12 (12 months after extraction).

Secondary Outcomes (15)

  • Analyze the mid-vestibular gingival level of the treated tooth.

    At T0(initial) before extraction

  • Analyze the mid-vestibular gingival level of the treated tooth.

    At T6 (6 months after extraction)

  • Analyze the mid-vestibular gingival level of the treated tooth.

    At T12 (12 months after extraction).

  • Measure the band of keratinized tissue around the treated tooth

    At T0(initial) before extraction

  • Measure the band of keratinized tissue around the treated tooth

    At T6 (6 months after extraction)

  • +10 more secondary outcomes

Study Arms (2)

Xenogenic collagen matrix

EXPERIMENTAL

Volumetrically stable xenogenic collagen matrix

Device: Xenogenic collagen matrix

Autogenous connective tissue graft

ACTIVE COMPARATOR

Autogenous connective tissue graft obtained from the tuberosity area

Device: Autogenous connective tissue graft

Interventions

Xenogenic collagen matrixDEVICE

Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.

Xenogenic collagen matrix
Autogenous connective tissue graftDEVICE

Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.

Autogenous connective tissue graft

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adequate oral hygiene (21).
  • Sufficient interocclusal space (≥6 mm) to place a provisional crown without occlusion.
  • Presence of adjacent teeth. Only one tooth gap.
  • Presence of soft tissue and cortical buccal bone of the tooth to be extracted according to the classification of Elian et al. 2007
  • Adequate bone quantity in the apical region of the tooth to be extracted (assessed on the CBCT).

You may not qualify if:

  • Patients with medical conditions that affect bone and soft tissue metabolism.
  • Uncontrolled endocrine disorders.
  • Alcohol and drug abuse.
  • Previous history of immunodeficiency syndromes.
  • Patients who smoke\> 10 cigarettes a day.
  • Active periodontal disease.
  • Absence of a tooth adjacent to the tooth to be treated.
  • Oral lesions of the untreated mucosa.
  • Recent previous history (\<6 months) of local radiotherapy or chemotherapy.
  • Bruxism or severe parafunctions.
  • Pregnant patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Dental Ortiz-Puigpelat

Barcelona, 08028, Spain

RECRUITING

Central Study Contacts

Octavi Ortiz-Puigpelat, DDS, PhD

CONTACT

+34629831138octaviortiz@uic.es

Study Design

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

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 28, 2021

Study Start

April 27, 2021

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

ES(1)