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Two-Piece Zirconia Dental Implant vs Two-Piece Titanium Dental Implant- Randomized Clinical Control Trial

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ClinicalTrials.gov Identifier: NCT03336723
Recruitment Status : Not yet recruiting
First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Andre Chen, Instituto de Implantologia

Tracking Information
First Submitted Date  ICMJE November 5, 2017
First Posted Date  ICMJE November 8, 2017
Last Update Posted Date November 8, 2017
Estimated Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2017)
  • Osseointegration [ Time Frame: from T0 to T2 - 2 month ]
    measure if the healing process of bone was successful
  • Marginal bone loss [ Time Frame: 4 month after T0 ]
    measure bone level from T0 baseline to T3
  • IL1b concentration [ Time Frame: 4 month ]
    Measure IL fluid at T0 and T2 for IL1b characterization
  • IL6 concentration [ Time Frame: 4 month ]
    Measure IL fluid at T0 and T2 for IL1b characterization
  • Microbiologic samples [ Time Frame: 4 month ]
    Measure crevicular fluid at T0 and T2 for bacteria characterization
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two-Piece Zirconia Dental Implant vs Two-Piece Titanium Dental Implant- Randomized Clinical Control Trial
Official Title  ICMJE Inflammation and Microbiology Pattern on Two-piece Zirconia Dental Implant Compared to Titanium Dental Implants. Randomized Clinical Control Trial
Brief Summary 2 Arms (60 subjects - 30 each arm). Experimental group with two-pice zirconia dental implant and Control group with two-piece titanium dental implant Evaluate Changes in inflammatory and microbiology levels from T0 (baseline) T2 (8 weeks) and T3 (after crown placement) Also evaluate secondary outcomes: marginal bone loss (MBL), gingival height (GH) levels, osseointegration, gender, age, time of surgery, anatomical position and implant stability. p values<0.05 were considered statistically significant
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osseointegration Failure of Dental Implant Due to Infection
  • Osseointegration Failure of Dental Implant Prior to Intentional Prosthetic Loading
Intervention  ICMJE Device: Dental Implant
Place a two piece zirconia dental implant on a healed ridge. At baseline, two month and crown placement take fluid samples with adsorbent paper in the per- implant crevicular fluid. At t2 and t3 repeat sample taken
Study Arms  ICMJE
  • Experimental: Experimental Group
    Two piece zirconia dental implants place subcrestally with a healing abutment at baseline (T0) and rehabilitated with a zirconia dental crown T3 3 Measures on the IL1b and IL6 at T0 baseline , T2 2 month and T3 at crown placement.Microbiological samples at T2 and T3.
    Intervention: Device: Dental Implant
  • Active Comparator: Control Group
    Two piece titanium dental implants place subcrestally with a healing abutment at baseline (T0) and rehabilitated with a zirconia dental crown T3 3 Measures on the IL1b and IL6 at T0 baseline , T2 2 month and T3 at crown placement.Microbiological samples at T2 and T3.
    Intervention: Device: Dental Implant
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2019
Estimated Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Single implants in any area (maxillary and mandibular), extracted teeth for at least 3 months before implant placement, with bone volumes sufficient (at least 2 mm mesial, distal, buccal and palatal) to accommodate dental implant without the need for regeneration. Controlled oral hygiene, absence of any lesions in the oral cavity, at least 2 mm keratinized tissue. In addition, patients must agree to participate in a postoperative control program and signed the informed consent.

Exclusion Criteria:

1 - allergic to local anaesthetics, or any of the other components. 2 - Patients with hepatic or renal dysfunction 3 - Patients with epilepsy, shock, cardiac conduction disorders or myasthenia gravis 4 - Patients with myocardial injury 5 - Hyperthyroidism 6 - Severe Hypertension 7 - Insufficient bone volume 8 - Smoking more than five cigarettes / day 9 - Excessive alcohol consumption 10 - localized anti-tumour radiation therapy of the oral cavity 11 - Chemotherapy 12 - Liver Diseases 13 - immunosuppressed patients 14 - Patients taking corticosteroids 15 - Pregnancy 16 - inflammatory and autoimmune diseases of the oral cavity

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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: Elena cervino, DMD 00351919774343 elecer@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03336723
Other Study ID Numbers  ICMJE II10
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andre Chen, Instituto de Implantologia
Study Sponsor  ICMJE Instituto de Implantologia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Instituto de Implantologia
Verification Date November 2017

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