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Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss Collagen and Mucograft Seal

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ClinicalTrials.gov Identifier: NCT03395145
Recruitment Status : Unknown
Verified April 2018 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Study Description
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Brief Summary:
Evaluation of Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal compared to natural healing after tooth extraction

Condition or disease Intervention/treatment Phase
Bio-Oss; Mucograft Device: Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal Not Applicable

Detailed Description:

In the last decade dental implants have become widely used for oral rehabilitation. But, the usage of dental Implants might be difficult in cases of alveolar bone deficiencies.

Different ridge preservation techniques were successfully used, using membrane with or without bone substitutes.new grafting material is Mucograft Seal, a collagen matrix graft, which originally used as an alternative to the connective tissue graft for the treatment of gingival recessions. Mucograft has demonstrated a good tissue reaction with high biocompatibility and a low shrinkage tendency, in order to increase the amount of keratinized gingiva in the augmented area.

Study Hypothesis: The observed changes in ridge dimensions when using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal as ridge preservation will be less pronounced in comparison to natural healing after tooth extraction.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Valuation of Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal Compared to Natural Healing After Tooth Extraction
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bio-Oss Collagen and Mucograft Seal
Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal
 Device: Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal
Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation after tooth extraction
No Intervention: Natural healing
Evaluation of Bone volume Changes after tooth extraction (natural healing)


Outcome Measures
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Primary Outcome Measures :
  1. socket width mm [ Time Frame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading ]

    The socket width (buccal-lingual aspect) will be assessed at the following reference points:

    1. 3-(∆ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact.
    2. 5-(∆ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact.
    3. The width of each cortical buccal and lingual bone plate, 3 millimeters apical to the alveolar crest.
    4. The width of each cortical buccal and lingual bone plate, 5 millimeters apical to the alveolar crest.

  2. alveolar height mm [ Time Frame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading ]
    Alveolar crest height (ACH) will be measured from the apical part of the stent to the bone crest at the mid M-D distance of the socket.

  3. keratinized tissue mm [ Time Frame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading ]
    In the lower jaw the keratinized tissue width will be measured from the apical part of the stent to the mucogingival line on the buccal and lingual sides. On the upper jaw only the keratinized tissue on the buccal side will be measured.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Patients of 18 years or older.
  • Patients in need of a tooth extraction in the area of premolars, canines or incisors due to periodontal and/or dental reasons, provided that the socket walls are intact (bone dehiscence of max. 4mm limited to one bone wall).
  • Patients who need implant placement at the site of extraction.

Exclusion Criteria:

  • Inability to complete or understand the informed consent process.
  • Bone dehiscence at extraction socket of more than 4 mm or 4 mm at more than one bony wall.
  • Pregnant or lactating women.
  • Patients who use medications that affect bone metabolism such as IV bisphosphonates.
  • Heavy smokers (more than 10 cigarettes per day).
  • Patients with removable prosthesis, which might compress the treated site.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03395145


Contacts
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Contact: Eli Machtei, DMD 9727772983 machtei@rambam.health.gov.il
Contact: Eran Gabay, DMD 7771636 eran.gabay@mail.huji.ac.il

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Eli Machtei, DMD Rambam Health Care Campus
More Information
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03395145    
Other Study ID Numbers: 0507-17-RMB CTIL
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No