Esthetic Outcomes of Immediately Placed Implants Receiving Immediate Provisionalization and Delayed Restoration

A single center, randomized controlled, parallel-arm study is planned to investigate esthetic
outcomes after immediate placement and restoration in the esthetic zone. Forty adult patients
who have a hopeless maxillary anterior or premolar tooth, with intact adjacent teeth will be
enrolled. A signed written informed consent will be obtained after he or she has been given
verbal and written information describing the nature and duration of the study. Subjects will
not be screened or treated until an informed consent has been obtained. Patient information
will be protected according to the privacy regulations of the Federal Health Insurance
Portability and Accountability Act of 1996 (HIPAA).

The enrolled patients will be randomly placed into one of two treatment groups, immediate
implant placement (IIP) and restoration group (IR) or the IIP + delayed restoration group
(DR). For all patients, the hopeless tooth will be extracted atraumatically and an implant
placed immediately. The decision will be made randomly to either restoring the implant
immediately (Test group) with a provisional crown or restoring the implant at 4 months after
implant placement (Control group). Outcome analyses will be performed until approximately
1-year after the implant surgery and primarily evaluate clinical and radiographic parameters
to determine the esthetic outcomes of immediately restored IIP implants, in comparison to
those immediately placed but restored in a delayed approach.

Inclusion Criteria:

- Male or female, aged 21 or older

- A minimum dentition of 20 permanent teeth (including natural rooted teeth or dental
implants; pontic of a fixed bridge is not considered a tooth)

- A maxillary premolar, canine, lateral incisor or central incisor with a hopeless
prognosis

- Presence of adjacent teeth and enough clearance for an implant crown

- Presence of sufficient bone apical to the root apex of the hopeless tooth

Exclusion Criteria:

Systemic criteria:

- Current heavy smokers (>10 cigarettes per day) or heavy smokers who quitted less than
1 year

- Pregnant or plan to get pregnant or lactating mothers

- Diseases of the immune system or any medical condition that may influence the outcome
(uncontrolled diabetes (HbA1c >7), neurologic or psychiatric disorders, systemic
infections, …)

- Radiation therapy in the head and neck area within 3 years

- Current use of oral bisphosphonates for >3 years

- History of IV bisphosphonates use

- Other medical conditions that may contradict an implant surgery

Intraoral criteria:

- Area of study is adjacent to an existing implant

- Acute infection at/or adjacent to the extraction site (e.g., sinus tract, swelling,
etc.)

- Observable gingival changes due to use of medications such as calcium antagonists,
anticonvulsives, immunosuppressives, anti-inflammatory medications, etc.)

- Untreated deep carious lesions or defective restorations that can potentially
exacerbate during the course of the experiment

- Uncontrolled periodontal disease

- Poor oral hygiene (>20% FMPS)

CBCT criteria:

• More than 4 mm of buccal plate dehiscence is present on CBCT scans

Intraoperative criteria:

• More than 4 mm of buccal plate dehiscence is present once the tooth is extracted