Clinical trial NCT02814149: Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement
Official title: Esthetic, Clinical and Radiographic Outcomes of Immediate Implant Placement and Delayed Implant Placement in the Anterior Region of the Maxilla
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Jaw, Edentulous, Partially
Acquired Absence of Single Tooth
Keywords: delayed implant
esthetics
immediate implant
bone augmentation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective cohort study is to compare the esthetic, clinical and patient-centered outcomes following immediate and delayed implant placement protocols.

Detailed description: Patients are divided into two groups: immediate and delayed implant placement. The investigators are asking subjects to take part in a research study of soft tissue and bone 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.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old and able to understand an informed consent
* Adequate oral hygiene to allow for implant therapy consistent with standards of care.
* Missing a single tooth in the maxillary anterior region
* Presence of adjacent natural teeth

Exclusion Criteria:

* Poor oral hygiene
* Severe parafunctional habits, for example, bruxing and clenching
* Presence of clinically active periodontal disease as expressed by probing pocket depths≥4 mm in combination with bleeding on probing.
* Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease
* Pregnant or expecting to be pregnant
* History of drug and alcohol abuse
* History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level \>7%)
* Radiotherapy in the head and neck area,
* On certain medications like bisphosphonates or steroids currently or within the past three months
* Absence of adjacent teeth
* Unwillingness to return for the follow-up examination
* Smokers (more than 20 cigarettes per day). Subjects smoking \<20 cigarettes per day were requested to stop smoking before and after surgery

Primary outcomes:
measure: Pink and white esthetic scores (PES/WES)
timeFrame: Up to 10 years after baseline
measure: Radiographic bone volume
timeFrame: Up to 10 years after baseline
Secondary outcomes:
measure: Implant survival
timeFrame: Up to 10 years after baseline
measure: Probing depth
timeFrame: Up to 10 years after baseline
measure: Modified plaque index
timeFrame: Up to 10 years after baseline
measure: Modified bleeding index
timeFrame: Up to 10 years after baseline
measure: Buccal marginal recession
timeFrame: Up to 10 years after baseline
measure: Papilla volume
timeFrame: Up to 10 years after baseline
measure: Width of keratinized gingiva
timeFrame: Up to 10 years after baseline
measure: Visual analogue scale (VAS)
timeFrame: Up to 10 years after baseline
measure: Oral health impact profile shortened version (OHIP-I)
timeFrame: Up to 10 years after baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guanghua School of Stomatology Hospital of Stomatology
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhuofan Chen
role: STUDY_DIRECTOR
References:
citation: Rieder D, Eggert J, Krafft T, Weber HP, Wichmann MG, Heckmann SM. Impact of placement and restoration timing on single-implant esthetic outcome - a randomized clinical trial. Clin Oral Implants Res. 2016 Feb;27(2):e80-6. doi: 10.1111/clr.12539. Epub 2014 Dec 12.
citation: Huynh-Ba G, Meister DJ, Hoders AB, Mealey BL, Mills MP, Oates TW, Cochran DL, Prihoda TJ, McMahan CA. Esthetic, clinical and patient-centered outcomes of immediately placed implants (Type 1) and early placed implants (Type 2): preliminary 3-month results of an ongoing randomized controlled clinical trial. Clin Oral Implants Res. 2016 Feb;27(2):241-52. doi: 10.1111/clr.12577. Epub 2015 Mar 10.