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

NCT ID: NCT01623739

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2016-05-31

Brief Summary

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.

Detailed Description

This controlled, randomized clinical trial (RCT) is designed to compare soft and hard tissue dimensional changes for two commonly used approaches for replacing a recently extracted tooth by means of a dental implant, i.e. immediate implant placement (Type 1) or early implant placement (Type 2). Additionally, this study will evaluate the association between the osseous anatomy and implant position with soft and hard tissue changes.

Extraction sites will include maxillary and mandibular anterior and premolar teeth having intact adjacent teeth. Implants placed for this study will be SLA surface, bone level design, Straumann BL RC (Bone Level Regular Cross-fit ) 4.1mm or BL NC (Bone Level Narrow Cross-fit ) 3.3mm diameter implants at 8, 10, 12 or 14mm in length.

Immediate implant placement (Type 1) resulting in a horizontal defect dimension (HDD) will receive bone grafting, using freeze dried bone allograft (FDBA)(Straumann Allograft GC®) and will be covered by a resorbable membrane (BioGide®).

For the implants randomized to type 2 implant placement, the extraction socket will be filled with a collagen plug and allowed to heal for 4 to 8 weeks before the implant will be placed. Simultaneous guided bone regeneration (GBR) will be performed using FDBA (Straumann Allograft GC®)and a resorbable collagen membrane (BioGide®). The type 2 implant placement procedure will follow the guidelines as described by Buser et al. (2008).

All implant placement will follow standard protocols utilizing tapping and placement according to the manufacturer's guidelines.

Conditions

Jaw, Edentulous, Partially; Acquired Absence of Single Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Type 1 implant placement

Placement of a dental implant: Implant is placed immediately following tooth extraction in one surgical procedure

Group Type: ACTIVE_COMPARATOR

Placement of a dental implant

Intervention Type: PROCEDURE

Type 1 implant placement Type 2 implant placement

Type 2 implant placement

Placement of a dental implant: 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.

Group Type: ACTIVE_COMPARATOR

Placement of a dental implant

Intervention Type: PROCEDURE

Type 1 implant placement Type 2 implant placement

Interventions

Placement of a dental implant

Type 1 implant placement Type 2 implant placement

Intervention Type: PROCEDURE

Other Intervention Names

Straumann; SLActive; Dental Implants

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Huynh-Ba, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

UTHSCSA Department of Periodontics

Locations

Graduate Periodontics, Dental School, UTHSCSA

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ITI 689_2010

Identifier Type: -

Identifier Source: org_study_id