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

NCT02154581 | Completed Results

• 2 other identifiers: ITI 799_2011HSC20130085H
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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. 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. 2.If the soft tissue around your tooth is thick, the implant will be placed without a soft tissue graft.

Conditions

Jaw, Edentulous, Partially; Acquired Absence of Single Tooth

Keywords

Dental implants; Esthetic score; Immediate implants; Gingival biotype

Outcome Measures

Primary Outcomes (1)

• Mid Facial Mucosal Level at Implant Site

  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 from Baseline to 3 months

Secondary Outcomes (5)

• PES/WES (Pink Esthetic Score, White Esthetic Score).

  Approximately 1 year after baseline

• Probing Depth

  Up to 1 year after baseline

• Modified Plaque Index

  Up to 1 year after baseline

• Modified Bleeding Index

  Up to 1 year after baseline

• Radiographic Bone Level

  Up to 1 year after baseline

Study Arms (2)

Type 1 implant and thin biotype

ACTIVE COMPARATOR

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.

Device: SLActive implant

Type 1 implant and thick biotype

ACTIVE COMPARATOR

In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.

Device: SLActive implant

Interventions

SLActive implant DEVICE

Also known as: Straumann, Dental Implants, Type 1 implant placement

Type 1 implant and thick biotype; Type 1 implant and thin biotype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is 18 years or older.
• Ability to understand and provide informed consent before starting the study.
• Ability and willingness to comply with all study requirements.
• The patient, if of child-bearing potential, has a negative urine pregnancy test.
• Adequate oral hygiene to allow for implant therapy consistent with standards of care.
• 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.
• 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.
• The site to be treated is surrounded by two natural teeth.
• Except the site to be treated, none of the maxillary incisors, canines and first pre-molars display marginal soft tissue recession.
• Following extraction, intact extraction socket bony walls are present.
• Primary stability of implant consistent with standards of care is achieved at the time of implant placement.
• 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.

You may not qualify if:

• 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.
• History of alcoholism or drug abuse within the past 5 years.
• Severe wear with an etiology of bruxism or clenching habits.
• 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.
• History of HIV infection, Hepatitis B or C.
• 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).
• Presence of local inflammation or mucosal diseases such as lichen planus.
• Patient history consistent with high risk for subacute bacterial endocarditis.
• Current hematological disorder or warfarin (or similar) therapy.
• 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.
• 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.
• 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.
• Patient currently undergoing chemotherapy.
• Patient history of radiation treatment to the head or neck.
• Physical or mental handicaps that would interfere with patient's ability to exercise good oral hygiene on a regular basis.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Graduate Periodontics, Dental School, UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Research Compliance Coordinator-Senior
• Organization: UT Health San Antonio

NijlandK@uthscsa.edu

210-567-8554

Study Officials

• Guy Huynh-Ba, DDS, MS

  UTHSCSA Department of Periodontics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: January 1, 2013
• Primary Completion: April 28, 2018
• Study Completion: April 28, 2018
• Last Updated: July 9, 2019
• Results First Posted: July 9, 2019

Record last verified: 2019-06

Locations

US (1)