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Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen®

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ClinicalTrials.gov Identifier: NCT03659617
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Theodoros Katsaros, DDS, MSD, University of Iowa

Brief Summary:

The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen® at 3, 6 and 9 months following tooth extraction in single-rooted tooth sites.

Subjects with single rooted teeth planned for extraction and replacement with endosseous dental implants will be recruited for the study based on the eligibility criteria and will be divided in three groups (Groups 1, 2 and 3).A cone-beam computed tomography (CBCT) scan will be obtained and reviewed to prepare for the surgical approach and evaluate the ridge dimensions, the tooth planned for extraction as well as the adjacent sites. After tooth extraction, the socket will be grafted with Bio-Oss Collagen® and, depending on the morphology of the extraction sockets, a collagen matrix (Mucograft® seal) and/or a restorable collagen membrane (BioGide®)will be placed to cover and stabilize the graft. Patients will return at 2 and 6 weeks post-extraction to evaluate the healing. A second CBCT will be obtained 2 weeks prior to implant placement to evaluate the ridge dimensions and compare them to the baseline data. Implant placement will take place at 12, 24 and 36 after tooth extraction for Groups 1, 2 and 3 respectively. A bone core biopsy will be obtained at the time of implant placement and will be sent for histological analysis. Patients will return for a post-operative visit at two weeks. Clinical indices (probing depth, recession, bleeding upon probing, keratinized mucosa height, plaque and gingival index), patient reported outcomes and marginal bone levels via standardized periapical radiographs will be evaluated and recorded at baseline (no more than 30 days following delivery of final implant restoration) 1, 2 and 3 years post-loading.


Condition or disease Intervention/treatment Phase
Tooth Loss Device: xenograft (BioOss Collagen) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessors collecting the data and conducting the appropriate statistical analyses for all outcomes in the study will be blinded.
Primary Purpose: Treatment
Official Title: Clinical, Radiographic and Histomorphotmetric Analysis of Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen®: A Prospective 3-year Post-loading Study
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: Implant placement 3 mo. after tooth ext.
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 mo. after tooth ext.
Device: xenograft (BioOss Collagen)
Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)

Active Comparator: Implant placement 6 mo. after tooth ext.
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 mo. after tooth ext.
Device: xenograft (BioOss Collagen)
Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)

Active Comparator: Implant placement 9 mo. after tooth ext.
Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 mo. after tooth ext.
Device: xenograft (BioOss Collagen)
Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)




Primary Outcome Measures :
  1. Implant survival [ Time Frame: 3 years post implant loading ]
    did the implant survive


Secondary Outcome Measures :
  1. % of vital bone via histomorphotmetric evaluation of bone core biopsies at 3 months [ Time Frame: 3 months ]
    % of vital bone

  2. % of vital bone via histomorphotmetric evaluation of bone core biopsies at 6 months [ Time Frame: 6 months ]
    % of vital bone

  3. % of vital bone via histomorphotmetric evaluation of bone core biopsies at 9 months [ Time Frame: 9 months ]
    % of vital bone

  4. Amount of mineralization via micro-CT analysis 3 months [ Time Frame: 3 months ]
    Amount of mineralization

  5. Amount of mineralization via micro-CT analysis 6 months [ Time Frame: 6 months ]
    Amount of mineralization

  6. Amount of mineralization via micro-CT analysis 9 months [ Time Frame: 9 months ]
    Amount of mineralization

  7. Linear Dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (3 months) [ Time Frame: 3 months ]
    Clinical and radiographic (via CBCT) assessment. The buccal - lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (3-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically.

  8. Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months) [ Time Frame: 6 months ]
    Clinical and radiographic (via CBCT) assessment. The buccal - lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (6-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically.

  9. Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (9 months) [ Time Frame: 9 months ]
    Clinical and radiographic (via CBCT) assessment. The buccal - lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (9-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically.

  10. Assessment of the mucosal maturation of the extraction sites after the use of Mucograft Seal® @ 1 week, using a wound healing index (1-3 scale rating) [ Time Frame: 1 week following tooth extraction and alveolar ridge preservation ]
    Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration

  11. Assessment of the mucosal maturation of the extraction sites after the use of Mucograft Seal® @ 2 weeks, using a wound healing index (1-3 scale rating) [ Time Frame: 2 weeks following tooth extraction and alveolar ridge preservation ]
    Wound Healing Index.1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration

  12. Assessment of the mucosal maturation of the extraction sites after the use of Mucograft Seal® @ 6 weeks, using a wound healing index (1-3 scale rating) [ Time Frame: 6 weeks following tooth extraction and alveolar ridge preservation ]
    Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration

  13. Assessment of the mucosal maturation following implant placement, using a wound healing index (1-3 scale rating) [ Time Frame: 2 weeks following dental implant placement ]
    Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration

  14. Patient reported outcomes (pain) 1 week following tooth extraction, using a Visual Analog Score for pain (0-100) [ Time Frame: 1 week following tooth extraction and alveolar ridge preservation ]
    Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

  15. Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100) [ Time Frame: 2 weeks following tooth extraction and alveolar ridge preservation ]
    Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

  16. Patient reported outcomes (pain) 6 weeks following tooth extraction, using a Visual Analog Score for pain (0-100) [ Time Frame: 6 weeks following tooth extraction and alveolar ridge preservation ]
    Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

  17. Patient reported outcomes (pain) 2 weeks following implant placement, using a Visual Analog Score for pain (0-100) [ Time Frame: 2 weeks following implant placement ]
    Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

  18. Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100) [ Time Frame: Up to 30 days post implant crown delivery ]
    The patients will be asked to rate their satisfaction in terms of function, comfort and esthetics, using a Visual Analog Scale (0-100, with 0 meaning "not at satisfied at all" and 100 corresponding to "perfectly satisfied").

  19. Marginal bone level changes [ Time Frame: 3 years post implant crown delivery ]
    measured in mm based on standardized intro-oral radiographs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • May be either male or female
  • Age: 18 years or older
  • Subjects with a single-rooted tooth (except mandibular incisors) indicated for extraction
  • Extractions socket walls should either be intact or have no more than one bony wall (buccal or lingual) dehiscence extending no more than 50% of the total bony wall height
  • Must be in adequate physical and mental health to undergo routine dental treatment including the surgical procedures associated tooth extraction and implant placement
  • Subjects' treatment plan must include replacement of the tooth to be extracted with dental implant supported fixed restoration
  • Subjects must have read, understood and signed an informed consent form

Exclusion Criteria:

  • Mandibular incisors
  • Acute infection associated with the tooth to be extracted or with adjacent teeth
  • History of significant heart, stomach, liver, kidney, blood, immune system disease, or other organ impairment or systemic diseases that would prevent undergoing the proposed treatment or may result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use [>10 cigs/day])
  • Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
  • Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
  • Pregnant women or nursing mothers
  • Subjects that are unwilling or unable to sign the informed consent
  • History of lack of compliance with dental visits
  • Subjects unwilling to return for the required number of visits

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): NCT03659617


Contacts
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Contact: Thedoros Katsaros 3193534276 theodoros-katsaros@uiowa.edu

Locations
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United States, Iowa
The University of Iowa College of Dentistry and Dental Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Theodoros Katsaros, DDS    319-353-4276    theodoros-katsaros@uiowa.edu   
Sponsors and Collaborators
Theodoros Katsaros, DDS, MSD
Investigators
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Principal Investigator: Theodoros Katsaros University of Iowa

Publications:

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Responsible Party: Theodoros Katsaros, DDS, MSD, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03659617     History of Changes
Other Study ID Numbers: 201806050
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Theodoros Katsaros, DDS, MSD, University of Iowa:
alveolar bone
alveolar ridge
bone resorption
bone grafting
barrier membrane

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases