Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Type 1 implant placement, Type 3 implant placement.
- Who it may be relevant to
- Registry conditions: Jaw, Edentulous, Partially, Acquired Absence of Single Tooth. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Esthetic, Clinical and Radiographic Outcomes of Immediate Implant Placement and Delayed Implant Placement in the Anterior Region of the Maxilla
Overview
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.
Interventions
- Procedure Type 1 implant placement
Implant is placed immediately following tooth extraction in one surgical procedure - Procedure Type 3 implant placement
Implant is placed in the site which is left to heal for 3 months following tooth extraction
Primary outcome measures
- Pink and white esthetic scores (PES/WES) [Time frame: Up to 10 years after baseline]
- Radiographic bone volume [Time frame: Up to 10 years after baseline]
Secondary outcome measures (9)
- Implant survival [Time frame: Up to 10 years after baseline]
- Probing depth [Time frame: Up to 10 years after baseline]
- Modified plaque index [Time frame: Up to 10 years after baseline]
- Modified bleeding index [Time frame: Up to 10 years after baseline]
- Buccal marginal recession [Time frame: Up to 10 years after baseline]
- Papilla volume [Time frame: Up to 10 years after baseline]
- Width of keratinized gingiva [Time frame: Up to 10 years after baseline]
- Visual analogue scale (VAS) [Time frame: Up to 10 years after baseline]
- Oral health impact profile shortened version (OHIP-I) [Time frame: Up to 10 years after baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guanghua School of Stomatology Hospital of Stomatology — Guangzhou
Publications
- 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. PMID 25496243
- 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. PMID 25758100
Identifiers
NCT: NCT02814149 · XinL