Tooth FracturesNCT04029324
Clinical Outcomes of Immediate Implant Placement and Early Implant Placement
A study testing tooth extraction, Implant placement and Bone augmentation in people with Tooth Fractures and Tooth Diseases, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Immediate implant placement (IIP) has been an attractive treatment concept for both patients and clinicians due to reduced surgical interventions and total treatment span. Although soft-tissue alterations or midfacial recession have been demonstrated in previous studies, recent studies have reported positive result… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Fractures, Tooth Diseases
- What is being tested?
- tooth extraction, Implant placement and Bone augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2019to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≧18 years
- single hopeless teeth in anterior maxilla
- enough apical bone volume to achieve primary stability (>4mm)
Who cannot join
- active periodontoal infection
- incomplete buccal bone plate
- unwilling to participate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai NinthPeoples' Hospital
Shanghai, 200011
Xiao Zhang, Master, 8623271699
About this study
Official title: Clinical Outcomes of Immediate Implant Placement and Early Implant Placement: a Randomized Controlled Clinical Trial
Immediate implant placement (IIP) has been an attractive treatment concept for both patients and clinicians due to reduced surgical interventions and total treatment span. Although soft-tissue alterations or midfacial recession have been demonstrated in previous studies, recent studies have reported positive result following IIP with the modification of surgical interventions. However, high-quality evidence (≥Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of IIP with early implant placement (type 2) is limited.
- Conditions
- Tooth Fractures, Tooth Diseases
- Being tested
- tooth extraction, Implant placement, Bone augmentation, Coronally repositioned flap
- Medical subject headings
- Tooth Fractures, Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth extractionProcedure or surgery
Under local anesthesia, tooth will be extracted atraumatically.
Implant placementProcedure or surgery
Dental implants will be placed according to the instructions in fresh sockets or alveolar ridge.
Bone augmentationProcedure or surgery
Bone substitute will be used to augment or maintain the bone contour.
Coronally repositioned flapProcedure or surgery
After periosteal releasing incision, mucoperiosteal flap will be sutured at a more coronally position
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant placement | Active comparator | Implants are placed immediately after extraction Receives: Procedure: tooth extraction; Procedure: Implant placement; Procedure: Bone augmentation |
| Early implant placement | Placebo comparator | Implants are placed 4-8 weeks after extraction Receives: Procedure: tooth extraction; Procedure: Implant placement; Procedure: Bone augmentation; Procedure: Coronally repositioned flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midfacial recession
Recession of midfacial gingival level before extraction and 1-year follow-up
Measured: 1-year follow-up
Secondary outcomes (6)
Papillae recession
Recession of papillae before extraction and 1-year follow-up
Measured: 1-year follow-up
marginal bone loss
marginal bone level between crown delivery and 1-year follow-up
Measured: 1-year follow-up
Probing depth
Probing depth between crown delivery and 1-year follow-up
Measured: T2:crown delivery, T3: 1-year follow-up
Bleeding on probing %
Bleeding on probing % between crown delivery and 1-year follow-up
Measured: T2:crown delivery, T3: 1-year follow-up
Pink esthetic score
Measured: T2:crown delivery, T3: 1-year follow-up
Visual Analogue Scale assessement
Visual Analogue Scale on post-operative pain, esthetics and function
Measured: T1: immediately after surgery,T2:crown delivery, T3: 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start15 Jul 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth FracturesStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029324
- Sponsor's protocol ID
- 136-2019
- Status last verified
- Jan 2021
- First submitted
- 7 Jul 2019
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Immediate Implant Placement and Early Implant Placement: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04029324
- Acronym / sponsor ID
- 136-2019
- Conditions
- Tooth Fractures, Tooth Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 23 Jul 2019 (actual)
- 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.
Immediate implant placement (IIP) has been an attractive treatment concept for both patients and clinicians due to reduced surgical interventions and total treatment span. Although soft-tissue alterations or midfacial recession have been demonstrated in previous studies, recent studies have reported positive result following IIP with the modification of surgical interventions. However, high-quality evidence (≥Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of IIP with early implant placement (type 2) is limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implant placement | Active comparator | Procedure: tooth extraction, Procedure: Implant placement, Procedure: Bone augmentationImplants are placed immediately after extraction |
| Early implant placement | Placebo comparator | Procedure: tooth extraction, Procedure: Implant placement, Procedure: Bone augmentation, Procedure: Coronally repositioned flapImplants are placed 4-8 weeks after extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≧18 years
- single hopeless teeth in anterior maxilla
- enough apical bone volume to achieve primary stability (>4mm)
Key exclusion criteria (3 listed)
- active periodontoal infection
- incomplete buccal bone plate
- unwilling to participate
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 |
|---|---|---|
| tooth extractionUnder local anesthesia, tooth will be extracted atraumatically. | Procedure or surgery | Early implant placement, Immediate implant placement |
| Implant placementDental implants will be placed according to the instructions in fresh sockets or alveolar ridge. | Procedure or surgery | Early implant placement, Immediate implant placement |
| Bone augmentationBone substitute will be used to augment or maintain the bone contour. | Procedure or surgery | Early implant placement, Immediate implant placement |
| Coronally repositioned flapAfter periosteal releasing incision, mucoperiosteal flap will be sutured at a more coronally position | Procedure or surgery | Early implant placement |
Primary outcome
Midfacial recession
Time frame: 1-year follow-up
Recession of midfacial gingival level before extraction and 1-year follow-up
6 secondary outcomes
Papillae recession
Time frame: 1-year follow-up
marginal bone loss
Time frame: 1-year follow-up
Probing depth
Time frame: T2:crown delivery, T3: 1-year follow-up
Bleeding on probing %
Time frame: T2:crown delivery, T3: 1-year follow-up
Pink esthetic score
Time frame: T2:crown delivery, T3: 1-year follow-up
Visual Analogue Scale assessement
Time frame: T1: immediately after surgery,T2:crown delivery, T3: 1-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tooth extraction, Implant placement and Bone augmentation in people with Tooth Fractures and Tooth Diseases, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jan 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junyu Shi, Phd (8653315299, sakyamuni_jin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Midfacial recession (time frame: 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2021.