Comparison of Clinical Outcomes of Different Wound Closure Methods in Immediate Implant Placement in the Aesthetic Zone
NCT ID: NCT05127629
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-04-01
2022-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control
Immediate implant placement
After tooth extraction, a dental implant is placed immediately.
Guided bone regeneration
After implant placement, the gap between implant and the buccal bone wall is filled with Bio-oss collagen.
Wound closure with gelatin sponge
After guided bone regeneration, patient in the control group receive gelatin sponge for wound closure.
Collagen matrix
Immediate implant placement
After tooth extraction, a dental implant is placed immediately.
Guided bone regeneration
After implant placement, the gap between implant and the buccal bone wall is filled with Bio-oss collagen.
Wound closure with collagen matrix
After guided bone regeneration, patient in the control group receive collagen matrix (Mucograft Seal) for wound closure.
Interventions
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Immediate implant placement
After tooth extraction, a dental implant is placed immediately.
Guided bone regeneration
After implant placement, the gap between implant and the buccal bone wall is filled with Bio-oss collagen.
Wound closure with gelatin sponge
After guided bone regeneration, patient in the control group receive gelatin sponge for wound closure.
Wound closure with collagen matrix
After guided bone regeneration, patient in the control group receive collagen matrix (Mucograft Seal) for wound closure.
Eligibility Criteria
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Inclusion Criteria
2. Single tooth in the maxillary anterior aesthetic area to be extracted for immediate implant placement;
3. The labial bone plate is intact and there is sufficient bone in the apical region to ensure initial stability.
4. Healthy intraoral soft tissues and no infection.
Exclusion Criteria
2. Heavy smokers (\> 10 cigarettes/day).
3. 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.
4. Patients with uncontrolled periodontitis and unstable periodontal status.
5. Lateral labial bone plate defect;
6. Missing teeth;
7. Allergic to titanium;
e. Those who do not wish to participate in this study.
18 Years
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Responsible Party
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Junyu Shi
Principal Investigator
Locations
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Department of Oral and Maxillofacial Implantology
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jun-Yu Shi, MDS
Role: primary
Other Identifiers
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20210205.V1
Identifier Type: -
Identifier Source: org_study_id
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