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Ridge Regeneration in Three Wall Sockets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03548896
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : July 10, 2018
Information provided by (Responsible Party):
Pedro Diz Iglesias, Universitat Internacional de Catalunya

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.

Condition or disease Intervention/treatment Phase
Dental Implant Socket Preservation Procedure: Post extraction socket Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dimensional Changes Following Ridge Augmentation of the Buccal Wall in Dehiscence Sockets: a Randomized-controlled Clinical Trial.
Actual Study Start Date : February 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Dental Implants
Dental implants Titanium SLA treated surface of different dimensions according to the specific needs of the patient
Procedure: Post extraction socket
**Dental implant will be placed 3 months after tooth extraction

Experimental: Resorbable membrane
Resorbable membrane Cross link collagen membrane from porcine animal with a measure of 15 x 25 mm
Procedure: Post extraction socket
**Dental implant will be placed 3 months after tooth extraction

Experimental: Allograft
Allograft Bone from human source that is administered in a dosage of 1 cc per patient
Procedure: Post extraction socket
**Dental implant will be placed 3 months after tooth extraction

Primary Outcome Measures :
  1. total width of the buccolingual bone [ Time Frame: Baseline, 3 months, 1 year ]
    to evaluate the bone changes in cone beam computed tomography

Secondary Outcome Measures :
  1. keratinized tissue [ Time Frame: Baseline, 3 months and at 1 year ]
    to evaluate the height of keratinized tissue in millimeters

  2. soft tissue level [ Time Frame: Baseline, 3 months and at 1 year ]
    to evaluate the recession of the gingiva in millimeters

  3. pink esthetic score [ Time Frame: Baseline, 3 months and at 1 year ]
    evaluate the final delivery prosthesis over implant

  4. volumetric soft tissue changes (linear measurement) [ Time Frame: At 3 months and at 1 year ]
    To compare soft tissue changes between baseline and follow ups measured in millimeters

  5. radiographic bone loss (in millimeters) [ Time Frame: At 3 months, and at 1 year ]
    changes in periapical radiographs measured in millimeters from the implant neck to the first bone to implant contact

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men and women over 18 years old.
  2. 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).
  3. Presence of adjacent teeth.
  4. Anterior teeth (from second premolar to second premolar) of the maxilla.
  5. Patients who had requested an implant restoration between adjacent teeth
  6. Absence of active periodontal disease.
  7. Good level of oral hygiene (Plaque Index < 25%; (27).
  8. Absence of systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes mellitus, osteoporosis, biphosphonate medication).
  9. Non-smokers or light smokers (< 10 cigarettes per day).
  10. Written informed consent signed.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03548896

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Contact: DIZ +34 630793155 ext +34 PEDRODIZIGLESIAS@GMAIL.COM
Contact: DIZ 630793155 ext +34

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Universitat Internacional de Catalunya Recruiting
Barcelona, Catalunya, Spain, 08017
Contact: PEDRO DIZ IGLESIAS    630793155 ext +34      
Sponsors and Collaborators
Universitat Internacional de Catalunya
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Principal Investigator: PEDRO DIZ Universitat Internacional de Catalunya
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Responsible Party: Pedro Diz Iglesias, Principal investigator, Universitat Internacional de Catalunya Identifier: NCT03548896    
Other Study ID Numbers: PER 2016-02
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pedro Diz Iglesias, Universitat Internacional de Catalunya: