Dental Implant Clinical Trial
Official title:
A Prospective Clinical Study to Evaluate the Outcome of Early Loading of Implants in the Maxillary Anterior Region With Alveolar Bone Defects
With the improvement of people's living standards, implant restoration has become an ideal method for partially and completely edentulous patients. Traditional classic implant theory suggests a 3-6 month undisturbed healing period is required before permanent loading can take place. However, this loading plan takes a long time and cannot timely meet the chewing function and aesthetic needs of patients with anterior maxillary tooth loss. Currently, with the continuous improvement of implant design and surface treatment techniques, the speed of implant-bone integration has been increasing, and early loading has gradually become a clinical option. After carefully reviewing the research conducted by domestic and international scholars on early loading of implants in the anterior maxillary region , we found that the cases included in the articles were patients with anterior maxillary tooth loss who did not require simultaneous guided bone regeneration (GBR) surgery. It is well known that patients with anterior maxillary tooth loss often have significant alveolar bone defects. In such cases, GBR techniques are commonly used to repair the bone defect. However, due to the lack of relevant studies, the clinical loading strategies for implant cases with accompanying bone defects are relatively conservative. Clinically, a delayed loading restoration strategy is usually employed, which typically requires a delay of 6 months or even longer. However, delayed loading increases the patient's edentulous time, affects the function and stability of the dental arch, and increases the patient's psychological burden. Therefore, whether an early loading strategy can be used for implant cases with alveolar bone defects in the anterior maxillary region has become a key issue in clinical practice. However, there is few research reported on the timing and effectiveness of early loading of implants in the anterior maxillary region with accompanying alveolar bone defects. This study aims to evaluate the clinical effects of early loading in patients with anterior maxillary single-wall bone defects through a prospective clinical randomized controlled trial.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Age: 18-60 years; 2. Gender: Male or Female; 3. Patients with a single missing upper anterior tooth and a labial open-type single-wall bone defect who underwent simultaneous guided bone regeneration (GBR) surgery; 4. Patients choosing the ITI implant system; 5. Patients without a history of systemic diseases such as cardiovascular disease, hypertension, diabetes, etc.; 6. Patients with no history of periodontal disease or have undergone periodontal treatment and can maintain good oral hygiene with no smoking history; 7. Patients without a history of radiation therapy, hepatitis, tuberculosis, or any familial hereditary diseases; 8. Patients with a normal anterior occlusion. Exclusion Criteria: 1. Patients with bone defects other than labial open-type single-wall bone defects in the anterior region; 2. Patients with multiple consecutive missing upper anterior teeth; 3. Patients with a history of systemic diseases, infectious diseases, or familial hereditary diseases; 4. Patients with poor oral hygiene; 5. Patients with bruxism or teeth clenching. |
Country | Name | City | State |
---|---|---|---|
China | Stomatology Hospital Affiliated to Zhejiang University School of Medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
The Dental Hospital of Zhejiang University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | marginal bone resorption | The degree of bone resorption at the shoulder edge of the implant. Bone level was measured by a single reader on CBCT taken after implant surgery, temporary restoration, final restoration, and at the 12-month follow-up. | 1-2years | |
Secondary | Implant Success Rate | Implant success were assessed at suture removal, provisional restoration, final restoration, and at the 12-month follow-up. Implant success was defined according the criteria by Buser et al. ,i.e., absence of pain, foreign body discomfort or dysesthesia, absence of recurrent peri-implant infection with suppuration, absence of implant mobility, and absence of continuous peri-implant radiolucency. | 1-2years | |
Secondary | Complication rate | Complication were assessed at suture removal, provisional restoration, final restoration, and at the 12-month follow-up. Complication was defined Implant fracture,loose crowns and crowns breakage. | 1-2years | |
Secondary | PES index | peri-implant soft tissue index (PES). the PES comprises the following five variables : mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue color and texture at the facial aspect of the implant site. A score of 2, 1, or 0 is assigned to all five PES parameters. The five described parameters (5×2) add up, under optimum conditions, to a score of 10; the threshold of clinical acceptability was set at 6. | 1-2years | |
Secondary | probing depth | periodontal examination, in the form of probing depth (PD) , was performed at pre-screening ,final restoration and at the 12-month follow-up. | 1-2years | |
Secondary | probing bleeding index | periodontal examination, in the form of bleeding on probing (BoP), was performed at pre-screening ,final restoration and at the 12-month follow-up. | 1-2years | |
Secondary | Satisfaction assessed by the VAS | Patients answered five questions regarding their satisfaction on five parameters: prosthesis comfort, aesthetics, ability to chew, pronunciation and stability. Patients were asked to mark for each question the respective Visual Analog Scale (VAS) which is a 100 mm straight horizontal line with the left end indicating "not at all satisfied" and the right end "very satisfied". The satisfaction value was determined by the distance from the left end of the scale to the mark in millimeters and expressed as percentage (10 mm corresponds to 10%, 20 mm 20%, etc.) | 1-2years |
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