Jaw, Edentulous, PartiallyNCT02814149
Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement
A study testing Type 1 implant placement and Type 3 implant placement in people with Jaw, Edentulous, Partially and Acquired Absence of Single Tooth, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Jaw, Edentulous, Partially, Acquired Absence of Single Tooth
- What is being tested?
- Type 1 implant placement and Type 3 implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guanghua School of Stomatology Hospital of Stomatology
Guangzhou, Guangdong, 510000
Xin Liu, +8615902064014, 838667172@163.com
Baoxin Huang, +8615820219260, dentisthbx@163.com
About this study
Official title: Esthetic, Clinical and Radiographic Outcomes of Immediate Implant Placement and Delayed Implant Placement in the Anterior Region of the Maxilla
The aim of this prospective cohort study is to compare the esthetic, clinical and patient-centered outcomes following immediate and delayed implant placement protocols.
Read the 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.
- Being tested
- Type 1 implant placement, Type 3 implant placement
- Keywords
- delayed implant, esthetics, immediate implant, bone augmentation
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 1 implant placementProcedure or surgery
Also called Immediate implant placement
Implant is placed immediately following tooth extraction in one surgical procedure
Type 3 implant placementProcedure or surgery
Also called Delayed implant placement
Implant is placed in the site which is left to heal for 3 months following tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Type 1 implant placement | Active comparator | Implant is placed immediately following tooth extraction in one surgical procedure Receives: Procedure: Type 1 implant placement |
| Type 3 implant placement | Active comparator | Implant is placed in the site which is left to heal for 3 months following tooth extraction Receives: Procedure: Type 3 implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 10 years after baseline
Secondary outcomes (9)
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
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.
Measured: Up to 10 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Liu, Sun Yat-sen University
- Investigators
- Zhuofan Chen, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814149
- Sponsor's protocol ID
- XinL
- Status last verified
- Oct 2019
- First submitted
- 15 Jun 2016
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25496243Huynh-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.
PubMed 25758100
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic, Clinical and Radiographic Outcomes of Immediate Implant Placement and Delayed Implant Placement in the Anterior Region of the Maxilla
- ClinicalTrials.gov ID
- NCT02814149
- Acronym / sponsor ID
- XinL
- Keywords
- delayed implant, esthetics, immediate implant, bone augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 implant placement | Active comparator | Procedure: Type 1 implant placementImplant is placed immediately following tooth extraction in one surgical procedure |
| Type 3 implant placement | Active comparator | Procedure: Type 3 implant placementImplant is placed in the site which is left to heal for 3 months following tooth extraction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type 1 implant placementAlso: Immediate implant placementImplant is placed immediately following tooth extraction in one surgical procedure | Procedure or surgery | Type 1 implant placement |
| Type 3 implant placementAlso: Delayed implant placementImplant is placed in the site which is left to heal for 3 months following tooth extraction | Procedure or surgery | Type 3 implant placement |
Primary outcome
Pink and white esthetic scores (PES/WES)
Time frame: 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
Time frame: 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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 25496243Rieder 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.
- Background: PubMed 25758100Huynh-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhuofan Chen study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type 1 implant placement and Type 3 implant placement in people with Jaw, Edentulous, Partially and Acquired Absence of Single Tooth, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Liu (+8615902064014, 838667172@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink and white esthetic scores (PES/WES) (time frame: Up to 10 years after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02814149, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.