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Radiographic and the Esthetic Outcome of Two Different Bone Grafting Techniques in Early Implant Placement

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ClinicalTrials.gov Identifier: NCT03302143
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE September 26, 2017
First Posted Date  ICMJE October 4, 2017
Last Update Posted Date October 4, 2017
Actual Study Start Date  ICMJE July 30, 2013
Actual Primary Completion Date May 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2017)
Facial bone thickness [ Time Frame: Measured at 1 year post-loading ]
Facial bone thickness 1 year post-loading at 1, 3, and 5mm from the implant platform
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2017)
  • Change in facial bone thickness [ Time Frame: Between implant placement and 1 year post-loading ]
    Change in facial bone thickness between implant placement and 1 year post-loading
  • mPI measurement [ Time Frame: Measured at 6 and 12-months post-loading ]
    Measurement of modified Plaque Index
  • PD measurement [ Time Frame: Measured at 6 and 12-months post-loading ]
    Measurement of pocket depth
  • mSBI measurement [ Time Frame: Measured at 6 and 12-months post-loading ]
    Measurement of modified sulcus bleeding index
  • KM measurement [ Time Frame: Measured at 6 and 12-months post-loading ]
    Measurement of keratinized mucosa
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiographic and the Esthetic Outcome of Two Different Bone Grafting Techniques in Early Implant Placement
Official Title  ICMJE A Comparative, Randomized, Prospective, Clinical Study to Evaluate the Facial Bone and Esthetic Outcome of Buccal Augmentation Bone Grafting Techniques in Early (Type 2) Implant Placement
Brief Summary

Total of 48 subjects were randomly assigned to treatment groups:

UT Health Science Center at San Antonio Chi Mei Medical Center, Tainan, Taiwan

Patients require a maxillary non-molar extraction site that is planned to be replaced by a dental implant and crown. This includes Straumann BL SLActive: Narrow (3.3mm) & Regular (4.1mm) Crossfit implants in all available lengths.

Patients were randomly selected to receive either FDBA (test) or Autogenous bone + DBBM (control/standard) for contour augmentation.

Detailed Description

This comparative, randomized, prospective clinical study is designed to compare clinical outcomes and facial bone height and thickness of two different bone grafting techniques after augmentation in (Type 2) early implant placement.

Human subjects who could potentially qualify with the said inclusion criteria will be evaluated and screened. 24 human subjects who qualify for the procedure will have a thorough evaluation performed after obtaining consent from the patient. All subjects will require extraction of maxillary teeth (incisors, canines, premolars), followed by early implant placement of the missing teeth after 4 to 8 weeks extraction.

There will be two subject groups in this study in which the 24 human subjects in will randomly be placed by selecting the number "1" or "2" from a hat. 24 human subjects will be divided into two groups including 12 subjects using control group design and 12 subjects using test group design. 12 subjects will be placed randomly into Group 1 and will undergo the flapless extraction and early implant placement with GBR procedure using the control group design. 12 subjects will be placed randomly into Group 2 and will undergo the flapless extraction and early implant placement with GBR procedure using the test group design.

During the implant placement visit after 4 to 8 weeks of extraction, patient will be asked to select a number from a hat. If the number showed "1" as a control group, autograft , BBM and collagen membrane will be used as GBR materials after implant placement. If the number showed "2" as a test group, FDBA and collagen membrane will be used as GBR materials after implant placement.

Extraction sites will include maxillary teeth (11,12,13,14,15,21,22,23,24,25 according to FDI) having intact adjacent teeth. Implants placed for this study will have a SLActive surface, bone level design, Straumann NC 3.3mm or RC 4.1mm in diameter at all available implant lengths.

Control group: early implant placement with autograft plus BBM (Bio-Oss, Geistlich Pharm AG, Wolhausen, Switzerland) plus two layers of collagen membrane (BioGide®).

Test group: early implant placement with FDBA (Straumann Allograft GC®) plus two layers of collagen membrane (BioGide®).

These procedures will follow the guidelines as described by Buser et al. (2008). Implant placements will follow standard protocols utilizing tapping and placement with the hand ratchet.

A CBCT radiograph will be made during the screening visit to determine eligibility for the study and immediately following implant placement with GBR procedure to provide facial bone height and thickness measurements. The second CBCT procedure is not typically a standard of care procedure. After 12 months post loading healing time, the patient will receive another CBCT. This CBCT is also not a standard of care procedure but can accurately assess the amount of facial bone height and thickness maintained during the follow-up period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A comparative, randomized, prospective, clinical study
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Missing Tooth
  • Fractured Tooth
Intervention  ICMJE
  • Procedure: Guided bone regeneration with Bovine Bone Mineral
    Guided bone regeneration with Bovine Bone Mineral
  • Procedure: Guided bone regeneration with freeze dried bone allograft
    Guided bone regeneration with freeze dried bone allograft
Study Arms  ICMJE
  • Active Comparator: Control
    Guided bone regeneration with Bovine Bone Mineral
    Intervention: Procedure: Guided bone regeneration with Bovine Bone Mineral
  • Experimental: Experimental
    Guided bone regeneration with freeze dried bone allograft
    Intervention: Procedure: Guided bone regeneration with freeze dried bone allograft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2017)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 15, 2016
Actual Primary Completion Date May 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient is 18 years or older.
  2. Non-smoker or patient has smoking habit and < 1 pack per day.
  3. Ability to understand and provide informed consent before starting the study.
  4. Ability and willingness to comply with all study requirements.
  5. The patient, if of child-bearing potential, has a negative urine pregnancy test.
  6. Adequate oral hygiene to allow for implant therapy consistent with standards of care.
  7. Adequate primary stability following early implant placement protocols utilizing Straumann Bone Level implants NC 3.3mm or RC 4.1mm in diameter at all available implant lengths.
  8. One or more teeth in maxilla (11,12,13,14,15,21,22,23,24,25 according to FDI) has been identified as having a hopeless prognosis requiring extraction leading to a single-tooth gap requiring implant placement as determined by clinician.
  9. Implant site that has a defect and requires bone augmentation. This will be determined by measuring on the CBCT image the available space for the implant and whether or not there is enough bone width where the implant is to be placed.

Exclusion Criteria:

  1. Patient reports current smoking habit > 1 pack per day or tobacco chewing use.
  2. History of alcoholism or drug abuse within the past 5 years.
  3. Severe bruxism or clenching habits.
  4. Patient has significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
  5. History of HIV infection, Hepatitis B or C.
  6. Patients with a history of systemic disease that precludes standard dental implant therapy.
  7. Presence of local inflammation or mucosal diseases such as lichen planus
  8. Patient history consistent with high risk for subacute bacterial endocarditis
  9. Current hematological disorder or coumadin (or similar) therapy
  10. Patient currently undergoing chemotherapy
  11. Patient history of radiation treatment to the head or neck
  12. Physical or mental handicaps that would interfere with patient's ability to exercise good oral hygiene on a regular basis
  13. Pregnant or breastfeeding women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03302143
Other Study ID Numbers  ICMJE HSC20120264H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP