Tooth FractureNCT05127629
Comparison of Clinical Outcomes of Different Wound Closure Methods in Immediate Implant Placement in the Aesthetic Zone
A study testing Immediate implant placement, Guided bone regeneration and Wound closure with gelatin sponge in people with Tooth Fracture and Tooth Decay, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Implant-supported restorations have become one of the best treatment options for patients with tooth loss, with predictable long-term success rates and clinical outcomes. Immediate implant placement means the implant is placed immediately after tooth extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Fracture, Tooth Decay
- What is being tested?
- Immediate implant placement, Guided bone regeneration and Wound closure with gelatin sponge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are at least 18 years old and in good health;
- Single tooth in the maxillary anterior aesthetic area to be extracted for immediate implant placement;
- The labial bone plate is intact and there is sufficient bone in the apical region to ensure initial stability.
- Healthy intraoral soft tissues and no infection.
Who cannot join
- Need to place more than 1 implant in the aesthetic area.
- Heavy smokers (> 10 cigarettes/day).
- Patients with physical diseases such as: uncontrolled diabetes (fasting glucose > 7.2 mmol/L, glycosylated hemoglobin > 7%), current intake of bisphosphonate medication, history of head and neck malignancy, history of head and neck radiotherapy, pregnancy or preparation for pregnancy, etc.
- Patients with uncontrolled periodontitis and unstable periodontal status.
- Lateral labial bone plate defect;
- Missing teeth;
- Allergic to titanium;
- Those who do not wish to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oral and Maxillofacial Implantology
Shanghai, Shanghai Municipality, 200011
Jun-Yu Shi, MDS, 23271073
About this study
Implant-supported restorations have become one of the best treatment options for patients with tooth loss, with predictable long-term success rates and clinical outcomes. Immediate implant placement means the implant is placed immediately after tooth extraction. It can significantly reduce treatment time because extraction socket healing and implant osseointegration occur simultaneously. Immediate implant placement has many benefits, reducing the overall treatment time, reducing the patient's surgical procedures, and reducing surgical trauma (no flap reversal). However, the treatment also has significant limitations, including the inability to predict the possibility of bone and soft tissue healing, and the possibility of subsequent unfavorable esthetic outcomes. However, the evidence regarding soft and hard tissue and aesthetic outcomes in patients treated with immediate implants in the aesthetic area remains inconclusive. As the aesthetic success of implant restorations is increasingly valued over implant survival, there are significant clinical benefits to addressing immediate implant bone tissue resorption and soft tissue deficiencies and improving the aesthetic outcome of immediate implant restorations.
To address the potential health and aesthetic problems associated with soft and hard tissue deficiencies around dental implants, bone grafting in the jumping gap and soft tissue grafting procedures are often performed. According to literature, autologous soft tissue grafts have shown the best clinical and histological results in soft tissue regeneration techniques. However, it requires removal of tissue from the patient's donor area, which can add additional trauma. In contrast, gelatin sponges, currently commonly used as wound closure materials, are only hemostatic and rapidly absorbed postoperatively, and do not provide protection of hard and soft tissue augmentation. Collagen matrix has recently been introduced for keratinized gingival augmentation and has shown encouraging results in preclinical and clinical studies, but more information is needed to confirm its clinical efficacy. Mucograft® Seal is a porcine collagen matrix with a bilayer structure, a dense and slowly absorbing layer and a spongy layer that stabilizes blood clots and allows soft tissue cells to penetrate. Human gingival fibroblasts cultured on Mucograft® were demonstrated to have good proliferative properties and cell viability as scaffold material. In dog extraction sites, preliminary results suggest that the combination of Mucograft® and Bio-Oss Collagen may be an effective method for alveolar ridge preservation. Mucograft® Seal can be used in combination with Bio-Oss Collagen® for alveolar ridge preservation after tooth extraction.
Read more
The research hypothesis is that the use of a collagen matrix to seal the wound in immediate implant placement in aesthetic area will reduce buccal bone resorption and increase the width and thickness of the soft tissue at the implant site.
Therefore, we designed this comparative clinical trial in which patients accept immediate implant placement in aesthetic area. The implant is placed after tooth extraction, and bone graft material Bio-Oss Collagen® is placed in the jump gap, and the wound was closed by different means (collagen matrix or gelatin sponge randomly). The clinical examination, CBCT imaging and histological evaluations were performed to compare the differences in clinical efficacy of the two wound closure methods. The primary outcome is the buccal bone thickness change at the immediate implant site 4 months after surgery.
- Conditions
- Tooth Fracture, Tooth Decay
- Being tested
- Immediate implant placement, Guided bone regeneration, Wound closure with gelatin sponge, Wound closure with collagen matrix
- Keywords
- Immediate implant placement
- Medical subject headings
- Tooth Fractures, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placementProcedure or surgery
After tooth extraction, a dental implant is placed immediately.
Guided bone regenerationProcedure or surgery
After implant placement, the gap between implant and the buccal bone wall is filled with Bio-oss collagen.
Wound closure with gelatin spongeProcedure or surgery
After guided bone regeneration, patient in the control group receive gelatin sponge for wound closure.
Wound closure with collagen matrixProcedure or surgery
After guided bone regeneration, patient in the control group receive collagen matrix (Mucograft Seal) for wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Procedure: Immediate implant placement; Procedure: Guided bone regeneration; Procedure: Wound closure with gelatin sponge |
| Collagen matrix | Experimental | Not described Receives: Procedure: Immediate implant placement; Procedure: Guided bone regeneration; Procedure: Wound closure with collagen matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the buccal bone
Change in labial alveolar bone thickness, including alveolar bone thickness and implant bone powder thickness
Measured: 4 months after implant surgery
Secondary outcomes (3)
gingival thickness
Change of gingival thickness
Measured: 4 months after implant surgery
success rate
success rate of implant
Measured: 4 months after implant surgery
Wound healing
Wound healing status
Measured: 2weeks and 4 months after implant surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Apr 2021
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth FractureStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 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
- NCT05127629
- Sponsor's protocol ID
- 20210205.V1
- Status last verified
- Mar 2022
- First submitted
- 9 Nov 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: ngc
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes of Different Wound Closure Methods in Immediate Implant Placement in the Aesthetic Zone
- ClinicalTrials.gov ID
- NCT05127629
- Acronym / sponsor ID
- 20210205.V1
- Conditions
- Tooth Fracture, Tooth Decay
- Keywords
- Immediate implant placement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Nov 2021 (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.
Implant-supported restorations have become one of the best treatment options for patients with tooth loss, with predictable long-term success rates and clinical outcomes. Immediate implant placement means the implant is placed immediately after tooth extraction. It can significantly reduce treatment time because extraction socket healing and implant osseointegration occur simultaneously. Immediate implant placement has many benefits, reducing the overall treatment time, reducing the patient's surgical procedures, and reducing surgical trauma (no flap reversal). However, the treatment also has significant limitations, including the inability to predict the possibility of bone and soft tissue healing, and the possibility of subsequent unfavorable esthetic outcomes. However, the evidence regarding soft and hard tissue and aesthetic outcomes in patients treated with immediate implants in the aesthetic area remains inconclusive. As the aesthetic success of implant restorations is increasingly valued over implant survival, there are significant clinical benefits to addressing immediate implant bone tissue resorption and soft tissue deficiencies and improving the aesthetic outcome of immediate implant restorations.
To address the potential health and aesthetic problems associated with soft and hard tissue deficiencies around dental implants, bone grafting in the jumping gap and soft tissue grafting procedures are often performed. According to literature, autologous soft tissue grafts have shown the best clinical and histological results in soft tissue regeneration techniques. However, it requires removal of tissue from the patient's donor area, which can add additional trauma. In contrast, gelatin sponges, currently commonly used as wound closure materials, are only hemostatic and rapidly absorbed postoperatively, and do not provide protection of hard and soft tissue augmentation. Collagen matrix has recently been introduced for keratinized gingival augmentation and has shown encouraging results in preclinical and clinical studies, but more information is needed to confirm its clinical efficacy. Mucograft® Seal is a porcine collagen matrix with a bilayer structure, a dense and slowly absorbing layer and a spongy layer that stabilizes blood clots and allows soft tissue cells to penetrate. Human gingival fibroblasts cultured on Mucograft® were demonstrated to have good proliferative properties and cell viability as scaffold material. In dog extraction sites, preliminary results suggest that the combination of Mucograft® and Bio-Oss Collagen may be an effective method for alveolar ridge preservation. Mucograft® Seal can be used in combination with Bio-Oss Collagen® for alveolar ridge preservation after tooth extraction.
The research hypothesis is that the use of a collagen matrix to seal the wound in immediate implant placement in aesthetic area will reduce buccal bone resorption and increase the width and thickness of the soft tissue at the implant site.
Therefore, we designed this comparative clinical trial in which patients accept immediate implant placement in aesthetic area. The implant is placed after tooth extraction, and bone graft material Bio-Oss Collagen® is placed in the jump gap, and the wound was closed by different means (collagen matrix or gelatin sponge randomly). The clinical examination, CBCT imaging and histological evaluations were performed to compare the differences in clinical efficacy of the two wound closure methods. The primary outcome is the buccal bone thickness change at the immediate implant site 4 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: Immediate implant placement, Procedure: Guided bone regeneration, Procedure: Wound closure with gelatin sponge |
| Collagen matrix | Experimental | Procedure: Immediate implant placement, Procedure: Guided bone regeneration, Procedure: Wound closure with collagen matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are at least 18 years old and in good health;
- Single tooth in the maxillary anterior aesthetic area to be extracted for immediate implant placement;
- The labial bone plate is intact and there is sufficient bone in the apical region to ensure initial stability.
- Healthy intraoral soft tissues and no infection.
Key exclusion criteria (8 listed)
- Need to place more than 1 implant in the aesthetic area.
- Heavy smokers (> 10 cigarettes/day).
- Patients with physical diseases such as: uncontrolled diabetes (fasting glucose > 7.2 mmol/L, glycosylated hemoglobin > 7%), current intake of bisphosphonate medication, history of head and neck malignancy, history of head and neck radiotherapy, pregnancy or preparation for pregnancy, etc.
- Patients with uncontrolled periodontitis and unstable periodontal status.
- Lateral labial bone plate defect;
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 |
|---|---|---|
| Immediate implant placementAfter tooth extraction, a dental implant is placed immediately. | Procedure or surgery | Collagen matrix, Control |
| Guided bone regenerationAfter implant placement, the gap between implant and the buccal bone wall is filled with Bio-oss collagen. | Procedure or surgery | Collagen matrix, Control |
| Wound closure with gelatin spongeAfter guided bone regeneration, patient in the control group receive gelatin sponge for wound closure. | Procedure or surgery | Control |
| Wound closure with collagen matrixAfter guided bone regeneration, patient in the control group receive collagen matrix (Mucograft Seal) for wound closure. | Procedure or surgery | Collagen matrix |
Primary outcome
Thickness of the buccal bone
Time frame: 4 months after implant surgery
Change in labial alveolar bone thickness, including alveolar bone thickness and implant bone powder thickness
3 secondary outcomes
gingival thickness
Time frame: 4 months after implant surgery
success rate
Time frame: 4 months after implant surgery
Wound healing
Time frame: 2weeks and 4 months after implant surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided. ngc
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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 Immediate implant placement, Guided bone regeneration and Wound closure with gelatin sponge in people with Tooth Fracture and Tooth Decay, 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 4 inclusion and 8 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 31 Mar 2022. 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 Beilei Liu, Doctor (13061800982, beilei_liu@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of the buccal bone (time frame: 4 months after implant surgery). 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 31 Mar 2022.