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The Effect of Platform-Matching Versus Platform-Switching Dental Implants on Peri-implant Hard and Soft Tissue Healing

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ClinicalTrials.gov Identifier: NCT02536716
Recruitment Status : Unknown
Verified January 2018 by Henry Greenwell, University of Louisville.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2015
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

Tracking Information
First Submitted Date  ICMJE August 28, 2015
First Posted Date  ICMJE September 1, 2015
Last Update Posted Date January 4, 2018
Actual Study Start Date  ICMJE August 2015
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
Marginal alveolar bone loss [ Time Frame: 12-months post dental implant placement ]
Bone loss will be measured radiographically using a stent
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • Buccal implant recession [ Time Frame: 12-months post dental implant placement ]
    Buccal implant recession will be measured using a North Carolina probe using the adjacent teeth and incisal edge of the crown
  • Papilla fill [ Time Frame: 12-months post dental implant placement ]
    Presence or absence of black triangle apical to the contact point
  • Buccal soft tissue thickness around implant [ Time Frame: 12-months post dental implant placement ]
    Thickness will be measured with an endodontic file using a rubber stopper (objective measure of tissue thickness by penetrating tissue and measuring the thickness in mm).
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 The Effect of Platform-Matching Versus Platform-Switching Dental Implants on Peri-implant Hard and Soft Tissue Healing
Official Title  ICMJE The Effect of Platform-Matching Versus Platform-Switching Using Standard Internal Versus Tapered Internal Plus Dental Implants on Peri-implant Hard and Soft Tissue Healing
Brief Summary To compare platform-switched implants to platform-matched implants for replacement of a single missing tooth and their effect on: 1) Interproximal alveolar crest level in relation to implant platform. 2) Buccal implant recession. 3) Presence or absence of black triangle apical to the contact point. 4) Implant Success. 5) Adequate buccal tissue thickness.
Detailed Description Thirty patients will have a dental implant placed. Fifteen patients will be randomly selected by a coin toss to receive a platform-switched implant while the other fifteen will receive platform-matched implant. Each patient will receive a diagnostic work-up including standardized radiographs (periapicals), study casts, clinical photographs, and a clinical examination of teeth adjacent to the edentulous sites. Pre-surgical preparation will include detailed oral hygiene instructions. Baseline data will be collected at initial exam, and at 2, 4, 6, and 12 months. Parameters measured will include: plaque index, gingival index, probing depth, keratinized tissue, bleeding on probing, and digital radiographic examination. Pre-surgical measurements will include: cemento-enamel junction to osseous crest on adjacent teeth by direct measurement at surgery, and by radiograph at baseline, 2, 4, 6, and 12 months, periodontal form, periodontal biotype, tooth shape, and papilla harmony. Patients will be randomly selected for treatment group assignment using a coin toss before surgery by the mentor. One investigator who is unaware of group assignment will perform all baseline examinations and all follow-up examinations. Means and standard deviations will be calculated for all parameters. A paired t-test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups. A sample size of 15 gives 80% statistical power to detect a difference of 0.5 mm of implant bone loss between groups. All surgical procedures will be completed by one operator under the direction of one mentor. Pre-surgical measurements will be taken first. Local anesthesia will be administered. The surgical procedure will consist of the reflection of full thickness flaps to expose the alveolar crest. The implant platform will be placed 3 to 4 mm apical to the mid-facial gingival margin using dental implant osteotomy drills for preparation of the site. The surgical procedures will be documented with clinical photographs. Sutures will be used to close the flap and bury the implant under the tissue. Records will be kept of healing periodically for the first 8 weeks, then at 4, 6 and 12 months. The test group will use a BioHorizons Tapered Internal Plus "platform-switched" implant. The control group will be BioHorizons standard Internal "platform-matched" implant. All patients will be seen at 1-2, 4, 6 and 8 weeks to monitor healing. At week 8 the implant will be uncovered surgically and provisionalized, and at the 4 month visit the final crown will be placed. Subsequent examinations will take place at 6 and 12 months. Post-surgically, patients will take an antibiotic (doxycycline hyclate 100 mg once a day for two weeks), an analgesic (Vicodin ES every 4-6 hours as needed for pain), and an anti-inflammatory agent (Naproxen 375mg every 12 hours for one week). At post-operative visits plaque removal, and oral hygiene instruction, as needed, will be performed along with clinical photographs and standardized radiographs as scheduled. The results of this study will allow comparison of peri-implant soft and hard tissue healing following placement of a BioHorizons "platform-switched" Tapered Internal Plus implant versus a standard Internal "platform-matched" implant in terms of the effect on marginal bone loss, buccal recession, and papilla fill.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Missing Tooth
Intervention  ICMJE
  • Procedure: Platform-matched dental implant
    A platform-matched dental implant will be placed surgically, restored with a crown and evaluated for up to 12 months.
  • Procedure: Platform-switched dental implant
    A platform-switched dental implant will be placed surgically, restored with a crown and evaluated for up to 12 months.
Study Arms  ICMJE
  • Active Comparator: Platform-matched dental implant
    Platform-matched dental implant placement to measure marginal bone loss, gingival margin position, and papilla fill.
    Intervention: Procedure: Platform-matched dental implant
  • Experimental: Platform-switched dental implant
    Platform-switched dental implant placement to measure marginal bone loss, gingival margin position, and papilla fill.
    Intervention: Procedure: Platform-switched 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 Unknown status
Actual Enrollment  ICMJE
 (submitted: January 2, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2015)
30
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Have one edentulous site bordered by 2 teeth.
  • 2. Healthy persons at least 18 years old.
  • 3. Understands and has signed the informed consent.

Exclusion Criteria:

  • 1. Patients with uncontrolled diabetes, immune disease, or systemic disease that significantly affects the periodontium.
  • 2. Previous head and neck radiation.
  • 3. Patients who have been on IV bisphosphonates or oral bisphosphonates for > 3 years.
  • 4. Smokers.
  • 5. Patients who need prophylactic antibiotics prior to dental procedures.
  • 6. Patients with allergy to any medication or material used in the study.
  • 7. Chemotherapy in the previous 12 months.
  • 8. Severe psychological problems.
  • 9. Patients unable to sign the informed consent.
  • 10. Pregnant patients.
  • 11. History of allergy to common dentifrice ingredients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02536716
Other Study ID Numbers  ICMJE 15.0448
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henry Greenwell, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henry Greenwell, DMD University of Louisville
PRS Account University of Louisville
Verification Date January 2018

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