Back to resultsEsthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement
Primary Purpose
Jaw, Edentulous, Partially, Acquired Absence of Single Tooth
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Type 1 implant placement
Type 3 implant placement
Sponsored by
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring delayed implant, esthetics, immediate implant, bone augmentation
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
Sites / Locations
- Guanghua School of Stomatology Hospital of StomatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Type 1 implant placement
Type 3 implant placement
Arm Description
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Implant survival
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
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
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
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
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
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
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)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02814149
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially, Acquired Absence of Single Tooth
Keywords
delayed implant, esthetics, immediate implant, bone augmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Type 1 implant placement
Arm Type
Active Comparator
Arm Description
Implant is placed immediately following tooth extraction in one surgical procedure
Arm Title
Type 3 implant placement
Arm Type
Active Comparator
Arm Description
Implant is placed in the site which is left to heal for 3 months following tooth extraction
Intervention Type
Procedure
Intervention Name(s)
Type 1 implant placement
Other Intervention Name(s)
Immediate implant placement
Intervention Description
Implant is placed immediately following tooth extraction in one surgical procedure
Intervention Type
Procedure
Intervention Name(s)
Type 3 implant placement
Other Intervention Name(s)
Delayed implant placement
Intervention Description
Implant is placed in the site which is left to heal for 3 months following tooth extraction
Primary Outcome Measure Information:
Title
Pink and white esthetic scores (PES/WES)
Description
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.
Time Frame
Up to 10 years after baseline
Title
Radiographic bone volume
Description
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.
Time Frame
Up to 10 years after baseline
Secondary Outcome Measure Information:
Title
Implant survival
Description
Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Time Frame
Up to 10 years after baseline
Title
Probing depth
Description
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.
Time Frame
Up to 10 years after baseline
Title
Modified plaque index
Description
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.
Time Frame
Up to 10 years after baseline
Title
Modified bleeding index
Description
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.
Time Frame
Up to 10 years after baseline
Title
Buccal marginal recession
Description
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.
Time Frame
Up to 10 years after baseline
Title
Papilla volume
Description
Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Time Frame
Up to 10 years after baseline
Title
Width of keratinized gingiva
Description
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.
Time Frame
Up to 10 years after baseline
Title
Visual analogue scale (VAS)
Description
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.
Time Frame
Up to 10 years after baseline
Title
Oral health impact profile shortened version (OHIP-I)
Description
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.
Time Frame
Up to 10 years after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Liu
Phone
+8615902064014
Email
838667172@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Baoxin Huang
Phone
+8615820219260
Email
dentisthbx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuofan Chen
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Guanghua School of Stomatology Hospital of Stomatology
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Liu
Phone
+8615902064014
Email
838667172@163.com
First Name & Middle Initial & Last Name & Degree
Baoxin Huang
Phone
+8615820219260
Email
dentisthbx@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25496243
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.
Results Reference
background
PubMed Identifier
25758100
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.
Results Reference
background
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Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement
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