Tooth FracturesPhase 3NCT03594019
Immediate Implant Placement With Connective Tissue Graft or Socket Shield
A Phase 3 study testing Connective tissue graft, socket shield technique and Immediate implant placement in people with Tooth Fractures, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The present study aims to evaluate the clinical outcomes of immediate implant placement with connective tissue graft or socket shield. Previous studies have demonstrate the intact buccal bone plate plays an important role in the stability of peri-implant soft tissue around immediately placed implants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Fractures
- What is being tested?
- Connective tissue graft, socket shield technique and Immediate implant placement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 1 Feb 2022
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in need of single implant treatment in anterior maxilla Patients with small dehiscence in the buccal bone plate （<2mm vertical bone loss and <5mm horizontal bone loss） Patients with natural teeth adjacent to implant site
Who cannot join
- Uncontrolled periodontal diseases Heavy smokers (>10 cigarettes/day) Unwilling to participate in the present study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital
Shanghai, 200011
Junyu Shi, MDS, 081-53315299, sakyamuni_jin@163.com
About this study
Official title: Immediate Implant Placement Without Connective Tissue Graft or Socket Shield: a Randomized Controlled Clincial Trial
The present study aims to evaluate the clinical outcomes of immediate implant placement with connective tissue graft or socket shield. Previous studies have demonstrate the intact buccal bone plate plays an important role in the stability of peri-implant soft tissue around immediately placed implants. However, it remains controverisal whether soft tissue stability could be achieved in immediate implant placement with connective tissue graft or socket shield.
- Conditions
- Tooth Fractures
- Being tested
- Connective tissue graft, socket shield technique, Immediate implant placement
- Keywords
- immediate implant placement, connective tissue graft, samll dehiscence
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graftProcedure or surgery
Connective tissue graft (CTG) is an oral and maxillofacial surgical procedure first described by Alan Edel in 1974. It includes the preparation the recipient site of tissue exhibiting recession by incising the gingival, obtaining the CTG from the donor site, securing the CTG at the recipient site and suturing the incised gingival tissue at both the donor and recipient sites.
socket shield techniqueProcedure or surgery
The procedure is used to split the teeth and preserve the buccal part
Immediate implant placementProcedure or surgery
The implant will be placed in the frest socket immediately after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Patients in the control group will follow the conventional treatment protocol combined with connective tissue graft. Briefly, hopeless tooth will be extracted atraumatically. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. Then, connective tissue graft will be harvest from palatal and fixed between bucall mocosa and bucall bone. Healing abutment will placed and collegan sponge will be used to seal the wound. After 4 months, implant impression and crown delivery will be finished. Receives: Procedure: Connective tissue graft; Procedure: Immediate implant placement |
| Test Group | Experimental | Patients in the test group will receive conventional immediate implant placement combined with socket shield technique. Briefly, the hopeless teeth will be splited from mesial and distal, the buccal part will be preseved and the palatal part will extracted. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. After 4 months, implant impression and crown delivery will be finished. Receives: Procedure: socket shield technique; Procedure: Immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
pink esthetic score （PES）
An objective index introduced by Furhauser et al. 2005
Measured: 1 year
Secondary outcomes (4)
mucosal recession
the mid-buccal mucosal level change from baseline to follow-up
Measured: 1 year
marginal bone loss
the mesial and dital marginal bone loss from baseline to follow-up evaluated by peri-apical X-ray.
Measured: 1 year
pocket probing depth
the pocket depth at six sites around implant will be detected by periodontal probe
Measured: 1 year
bleeding on probing
the percentage of bleeding after probing by periodontal probe
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Feb 2019
- Primary completion20 Dec 2021 (estimated)
- Study completion1 Feb 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- 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
- NCT03594019
- Sponsor's protocol ID
- 2017_0419
- Status last verified
- May 2019
- First submitted
- 11 Jul 2018
- Last updated
- 16 May 2019
- 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 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement Without Connective Tissue Graft or Socket Shield: a Randomized Controlled Clincial Trial
- ClinicalTrials.gov ID
- NCT03594019
- Acronym / sponsor ID
- 2017_0419
- Conditions
- Tooth Fractures
- Keywords
- immediate implant placement, connective tissue graft, samll dehiscence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 20 Jul 2018 (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.
The present study aims to evaluate the clinical outcomes of immediate implant placement with connective tissue graft or socket shield. Previous studies have demonstrate the intact buccal bone plate plays an important role in the stability of peri-implant soft tissue around immediately placed implants. However, it remains controverisal whether soft tissue stability could be achieved in immediate implant placement with connective tissue graft or socket shield.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Procedure: Connective tissue graft, Procedure: Immediate implant placementPatients in the control group will follow the conventional treatment protocol combined with connective tissue graft. Briefly, hopeless tooth will be extracted atraumatically. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. Then, connective tissue graft will be harvest from palatal and fixed between bucall mocosa and bucall bone. Healing abutment will placed and collegan sponge will be used to seal the wound. After 4 months, implant impression and crown delivery will be finished. |
| Test Group | Experimental | Procedure: socket shield technique, Procedure: Immediate implant placementPatients in the test group will receive conventional immediate implant placement combined with socket shield technique. Briefly, the hopeless teeth will be splited from mesial and distal, the buccal part will be preseved and the palatal part will extracted. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. After 4 months, implant impression and crown delivery will be finished. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in need of single implant treatment in anterior maxilla Patients with small dehiscence in the buccal bone plate （<2mm vertical bone loss and <5mm horizontal bone loss） Patients with natural teeth adjacent to implant site
Key exclusion criteria (1 listed)
- Uncontrolled periodontal diseases Heavy smokers (>10 cigarettes/day) Unwilling to participate in the present study
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 |
|---|---|---|
| Connective tissue graftConnective tissue graft (CTG) is an oral and maxillofacial surgical procedure first described by Alan Edel in 1974. It includes the preparation the recipient site of tissue exhibiting recession by incising the gingival, obtaining the CTG from the donor site, securing the CTG at the recipient site and suturing the incised gingival tissue at both the donor and recipient sites. | Procedure or surgery | Control Group |
| socket shield techniqueThe procedure is used to split the teeth and preserve the buccal part | Procedure or surgery | Test Group |
| Immediate implant placementThe implant will be placed in the frest socket immediately after tooth extraction | Procedure or surgery | Control Group, Test Group |
Primary outcome
pink esthetic score （PES）
Time frame: 1 year
An objective index introduced by Furhauser et al. 2005
4 secondary outcomes
mucosal recession
Time frame: 1 year
marginal bone loss
Time frame: 1 year
pocket probing depth
Time frame: 1 year
bleeding on probing
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
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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 Phase 3 study testing Connective tissue graft, socket shield technique and Immediate implant placement in people with Tooth Fractures, 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 1 inclusion and 1 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 16 May 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (081 53315299, sakyamuni_jin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pink esthetic score （PES） (time frame: 1 year). 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 16 May 2019.