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Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone

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ClinicalTrials.gov Identifier: NCT02154581
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
ITI International Team for Implantology, Switzerland
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE May 30, 2014
First Posted Date  ICMJE June 3, 2014
Results First Submitted Date  ICMJE April 11, 2019
Results First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Study Start Date  ICMJE January 2013
Actual Primary Completion Date April 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
Mid Facial Mucosal Level at Implant Site [ Time Frame: Change from Baseline to 3 months ]
Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery.
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
Mid Facial Mucosal Level at Implant Site [ Time Frame: Up to 1 year after baseline ]
Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • PES/WES (Pink Esthetic Score, White Esthetic Score). [ Time Frame: Approximately 1 year after baseline ]
    Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 12 months after crown delivery. The PES (Pink Esthetic Score) and WES (White Esthetic Score) scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10, and then the two scores (PES and WES) added to give a total score out of 20, with 20 being the highest possible score (best outcome) and 0 being the worst outcome.
  • Probing Depth [ Time Frame: Up to 1 year after baseline ]
    Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline, 3 and 12 months after crown delivery. The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3 mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.
  • Modified Plaque Index [ Time Frame: Up to 1 year after baseline ]
    Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported.
  • Modified Bleeding Index [ Time Frame: Up to 1 year after baseline ]
    Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported.
  • Radiographic Bone Level [ Time Frame: Up to 1 year after baseline ]
    Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline 3, and 12 months after crown delivery. Radiographic bone measurements recorded following final restoration placement (baseline), after 3 and 12 months of loading, and change between these time points. A positive value indicates bone loss and a negative value indicates bone gain. BIC (Bone implant contact)= Distance from implant shoulder to first bone to implant contact.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
  • PES/WES (Pink Esthetic Score, White Esthetic Score). [ Time Frame: Up to 1 year after baseline ]
    Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery.
  • Probing Depth [ Time Frame: Up to 1 year after baseline ]
    Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery.
  • Modified Plaque Index [ Time Frame: Up to 1 year after baseline ]
    Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery.
  • Modified Bleeding Index [ Time Frame: Up to 1 year after baseline ]
    Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery.
  • Radiographic Bone Level [ Time Frame: Up to 1 year after baseline ]
    Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone
Official Title  ICMJE Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone: A Controlled Clinical Trial
Brief Summary

In this study a tooth that needs to be extracted will be replaced by an implant (artificial root) placed at the same appointment as the extraction. The investigators want to observe how the gums change shape with healing in two different scenarios:

  1. If the soft tissue around your tooth is thin, following extraction and implant placement an extra soft tissue graft (taken from your palate) in the area in order to increase the thickness of your gums after healing.
  2. If the soft tissue around your tooth is thick, the implant will be placed without a soft tissue graft.

Previous studies have shown that both methods work and can give good results. In fact the two methods are used routinely but they have never been compared objectively to one another in the same research study.

The main purpose of this study is to evaluate if there is any difference in terms of esthetic outcomes between these two treatment modalities after a crown has been placed on the implant.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Jaw, Edentulous, Partially
  • Acquired Absence of Single Tooth
Intervention  ICMJE Device: SLActive implant
Other Names:
  • Straumann
  • Dental Implants
  • Type 1 implant placement
Study Arms  ICMJE
  • Active Comparator: Type 1 implant and thin biotype
    In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
    Intervention: Device: SLActive implant
  • Active Comparator: Type 1 implant and thick biotype
    In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
    Intervention: Device: SLActive 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 Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2019)
41
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2014)
50
Actual Study Completion Date  ICMJE April 28, 2018
Actual Primary Completion Date April 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient is 18 years or older.
  2. Ability to understand and provide informed consent before starting the study.
  3. Ability and willingness to comply with all study requirements.
  4. The patient, if of child-bearing potential, has a negative urine pregnancy test.
  5. Adequate oral hygiene to allow for implant therapy consistent with standards of care.
  6. Adequate bone volume to accommodate the planned endosseous dental implant placement according to immediate placement protocols utilizing Straumann Bone Level implants RC (Regular Crossfit) 4.1mm or Bone Level Implant NC (Narrow Crossfit) 3.3 mm at 8, 10,12 or 14mm in length.
  7. One tooth in the anterior maxilla (first pre-molar to first pre-molar) requiring extraction resulting in a single- tooth gap planned to be restored with a dental implant as determined by the patient's dental provider.
  8. The site to be treated is surrounded by two natural teeth.
  9. Except the site to be treated, none of the maxillary incisors, canines and first pre-molars display marginal soft tissue recession.
  10. Following extraction, intact extraction socket bony walls are present.
  11. Primary stability of implant consistent with standards of care is achieved at the time of implant placement.
  12. Patient must be able to pay for fees related to the surgical implant placement related to extraction, grafting of the implant site, and half of the cost of the crown at the time of implant placement.

Exclusion Criteria:

  1. Patient reports tobacco use within the last five years. Tobacco use for this study is defined as a current smoking habit with moderate or heavy smoking (more than 10 cigarettes per day) or tobacco chewing use.
  2. History of alcoholism or drug abuse within the past 5 years.
  3. Severe wear with an etiology of 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 or alters daily activities to a level consistent with ASA (American Society of Anesthesiologists) III classification (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or psychiatric disorders).
  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 warfarin (or similar) therapy.
  10. Patient has a disease that affects bone metabolism, such as, but not limited to, osteoporosis, hyperthyroidism, hyperparathyroidism, congenital connective tissue disorders (e.g., osteogenesis imperfecta), or Paget's disease.
  11. Patient is taking medications or having treatments known to have an effect on bone turnover, including: thiazide diuretics, calcitonin, systemic steroids, bisphosphonates, vitamin D (>800 IU/day), estrogen or progesterone therapy.
  12. Current steroid treatment: defined as any person who within the last two years has received for two weeks a dose equivalent to 20 mg hydrocortisone.
  13. Patient currently undergoing chemotherapy.
  14. Patient history of radiation treatment to the head or neck.
  15. Physical or mental handicaps that would interfere with patient's ability to exercise good oral hygiene on a regular basis.
  16. Use of any investigational drug or device within the 30 day period immediately prior to implant surgery.
  17. Patient is pregnant.
  18. Extraction sites having anatomic conditions that preclude immediate implant placement.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02154581
Other Study ID Numbers  ICMJE ITI 799_2011
HSC20130085H ( Other Identifier: UTHSCSA IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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 ITI International Team for Implantology, Switzerland
Investigators  ICMJE
Principal Investigator: Guy Huynh-Ba, DDS, MS UTHSCSA Department of Periodontics
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date June 2019

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