Comparison of Clinical Outcomes of Different Wound Closure Methods in Immediate Implant Placement in the Aesthetic Zone
Primary Purpose
Tooth Fracture, Tooth Decay
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Immediate implant placement
Guided bone regeneration
Wound closure with gelatin sponge
Wound closure with collagen matrix
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Fracture focused on measuring Immediate implant placement
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
e. Those who do not wish to participate in this study.
Sites / Locations
- Department of Oral and Maxillofacial ImplantologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Collagen matrix
Arm Description
Outcomes
Primary Outcome Measures
Thickness of the buccal bone
Change in labial alveolar bone thickness, including alveolar bone thickness and implant bone powder thickness
Secondary Outcome Measures
gingival thickness
Change of gingival thickness
success rate
success rate of implant
Wound healing
Wound healing status
Full Information
NCT ID
NCT05127629
First Posted
November 9, 2021
Last Updated
March 28, 2022
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT05127629
Brief Title
Comparison of Clinical Outcomes of Different Wound Closure Methods in Immediate Implant Placement in the Aesthetic Zone
Official Title
Comparison of Clinical Outcomes of Different Wound Closure Methods in Immediate Implant Placement in the Aesthetic Zone
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Fracture, Tooth Decay
Keywords
Immediate implant placement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Collagen matrix
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Immediate implant placement
Intervention Description
After tooth extraction, a dental implant is placed immediately.
Intervention Type
Procedure
Intervention Name(s)
Guided bone regeneration
Intervention Description
After implant placement, the gap between implant and the buccal bone wall is filled with Bio-oss collagen.
Intervention Type
Procedure
Intervention Name(s)
Wound closure with gelatin sponge
Intervention Description
After guided bone regeneration, patient in the control group receive gelatin sponge for wound closure.
Intervention Type
Procedure
Intervention Name(s)
Wound closure with collagen matrix
Intervention Description
After guided bone regeneration, patient in the control group receive collagen matrix (Mucograft Seal) for wound closure.
Primary Outcome Measure Information:
Title
Thickness of the buccal bone
Description
Change in labial alveolar bone thickness, including alveolar bone thickness and implant bone powder thickness
Time Frame
4 months after implant surgery
Secondary Outcome Measure Information:
Title
gingival thickness
Description
Change of gingival thickness
Time Frame
4 months after implant surgery
Title
success rate
Description
success rate of implant
Time Frame
4 months after implant surgery
Title
Wound healing
Description
Wound healing status
Time Frame
2weeks and 4 months after implant surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
e. Those who do not wish to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beilei Liu, Doctor
Phone
13061800982
Email
beilei_liu@outlook.com
Facility Information:
Facility Name
Department of Oral and Maxillofacial Implantology
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-Yu Shi, MDS
Phone
23271073
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
ngc
Learn more about this trial
Comparison of Clinical Outcomes of Different Wound Closure Methods in Immediate Implant Placement in the Aesthetic Zone
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