Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Institut Straumann AG
Information provided by (Responsible Party):
Guy Huynh-Ba, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01623739
First received: April 26, 2012
Last updated: August 13, 2013
Last verified: January 2013
  Purpose

The investigators are asking subjects to take part in a research study of soft tissue (gums) and bone (jawbone) healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios:

  1. When the implant is placed at the same time the tooth is extracted.
  2. When the tooth is extracted and then left to heal for a period of 4 to 8 weeks before the implant is placed.

Previous studies have shown that both methods work and can give good results. In fact the two methods are used routinely as part of standard care but it is not known if the two procedures are equally good since they have never been compared in one same research study.


Condition Intervention
Jaw, Edentulous, Partially
Acquired Absence of Single Tooth
Procedure: Placement of a dental implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2)

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Mid facial mucosal level at implant site [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]
    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, 24, 36, 48, 60 months after crown delivery.


Secondary Outcome Measures:
  • PES/WES (pink esthetic score, white esthetic score). [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]
    Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.

  • Probing depth [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]
    Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.

  • Modified plaque index [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]
    Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.

  • Modified bleeding index [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]
    Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.

  • Radiographic bone level [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]
    Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.


Estimated Enrollment: 44
Study Start Date: December 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Type 1 implant placement
Implant is placed immediately following tooth extraction in one surgical procedure
Procedure: Placement of a dental implant
Type 1 implant placement Type 2 implant placement
Other Names:
  • Straumann
  • SLActive
  • Dental Implants
Active Comparator: Type 2 implant placement
Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.
Procedure: Placement of a dental implant
Type 1 implant placement Type 2 implant placement
Other Names:
  • Straumann
  • SLActive
  • Dental Implants

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 following immediate placement protocols utilizing Straumann Bone Level implants RC 4.1mm or Bone Level Implant NC 3.3 mm at 8, 10, 12 or 14 mm in length.
  7. One or more teeth in either the maxilla or mandible anterior or premolar areas requiring extraction leading to a single-tooth gap requiring implant placement as determined by the patient's dental provider.
  8. Following extraction, surgical site anatomy presents conditions allowing immediate implant placement.
  9. Primary stability of implant consistent with standards of care is achieved at the time of placement.

Exclusion Criteria:

  1. Patient reports 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 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 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 coumadin (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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623739

Locations
United States, Texas
Graduate Periodontics, Dental School, UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Institut Straumann AG
Investigators
Principal Investigator: Guy Huynh-Ba, DDS, MS UTHSCSA Department of Periodontics
  More Information

No publications provided

Responsible Party: Guy Huynh-Ba, Assistant Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01623739     History of Changes
Other Study ID Numbers: ITI 689_2010
Study First Received: April 26, 2012
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Dental implants
Esthetic score
Immediate implants
Early placement

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on April 16, 2014