Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
November 1, 2019
October 1, 2019
10.6 years
June 15, 2016
October 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pink and white esthetic scores (PES/WES)
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.
Up to 10 years after baseline
Radiographic bone volume
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.
Up to 10 years after baseline
Secondary Outcomes (9)
Implant survival
Up to 10 years after baseline
Probing depth
Up to 10 years after baseline
Modified plaque index
Up to 10 years after baseline
Modified bleeding index
Up to 10 years after baseline
Buccal marginal recession
Up to 10 years after baseline
- +4 more secondary outcomes
Study Arms (2)
Type 1 implant placement
ACTIVE COMPARATORImplant is placed immediately following tooth extraction in one surgical procedure
Type 3 implant placement
ACTIVE COMPARATORImplant is placed in the site which is left to heal for 3 months following tooth extraction
Interventions
Implant is placed immediately following tooth extraction in one surgical procedure
Implant is placed in the site which is left to heal for 3 months following tooth extraction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guanghua School of Stomatology Hospital of Stomatology
Guangzhou, Guangdong, 510000, China
Related Publications (2)
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: 25496243BACKGROUNDHuynh-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: 25758100BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhuofan Chen
Sun Yat-sen University
Central Study Contacts
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
- PRINCIPAL INVESTIGATOR
- PI Title
- post graduate
Study Record Dates
First Submitted
June 15, 2016
First Posted
June 27, 2016
Study Start
May 1, 2016
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
November 1, 2019
Record last verified: 2019-10