Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Type 1 implant placement Implant is placed immediately following tooth extraction in one surgical procedure |
Procedure: Type 1 implant placement
Implant is placed immediately following tooth extraction in one surgical procedure
Other Names:
|
| Active Comparator: Type 3 implant placement Implant is placed in the site which is left to heal for 3 months following tooth extraction |
Procedure: Type 3 implant placement
Implant is placed in the site which is left to heal for 3 months following tooth extraction
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pink and white esthetic scores (PES/WES) [Up to 10 years after baseline]
Baseline will be at the time of implant placement.Pink and white esthetic scores (PES/WES) will be recorded at 0.5, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
- Radiographic bone volume [Up to 10 years after baseline]
Radiographic bone volume be assessed at pre-operation, 0 ,1.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Secondary Outcome Measures
- Implant survival [Up to 10 years after baseline]
Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
- Probing depth [Up to 10 years after baseline]
Probing depth will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
- Modified plaque index [Up to 10 years after baseline]
Modified plaque index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
- Modified bleeding index [Up to 10 years after baseline]
Modified bleeding index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
- Buccal marginal recession [Up to 10 years after baseline]
Buccal marginal recession will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
- Papilla volume [Up to 10 years after baseline]
Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
- Width of keratinized gingiva [Up to 10 years after baseline]
Width of keratinized gingiva will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
- Visual analogue scale (VAS) [Up to 10 years after baseline]
A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
- Oral health impact profile shortened version (OHIP-I) [Up to 10 years after baseline]
A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Eligibility Criteria
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 depthsâ„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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guanghua School of Stomatology Hospital of Stomatology | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Study Director: Zhuofan Chen, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- XinL