A Study of Early Loading of Implants in the Maxillary Anterior Region With Alveolar Bone Defects

NCT06068231 | Unknown

• 1 other identifier: DHZhejiangU#2022(073)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant

Keywords

Alveolar Bone Defects; Early Loading of Dental Impalnt; Dental Impalnt treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Implant Success Rate

  1-2years

• Complication rate

  1-2years

• PES index

  1-2years

• probing depth

  1-2years

• probing bleeding index

  1-2years

Study Arms (2)

early loading group

EXPERIMENTAL

Early Loading Group: Implants were loaded with temporary restorations between 48 hours and 3 months after implantation and had occlusal contact with opposing dentition. The early loading time point was set at 6-8 weeks after implantation in this study.

Device: Temporary Crown

Conventional Loading Group

ACTIVE COMPARATOR

Implants were loaded at least 3 months after implantation and had occlusal contact with opposing dentition.

Device: Permanent Crown

Interventions

Temporary Crown DEVICE

Implants were loaded with temporary restorations 6 to 8 weeks after implantation and had occlusal contact with opposing dentition.

Also known as: Early Loading

early loading group

Permanent Crown DEVICE

Implants were loaded with permanent restorations at least 3 months after implantation and had occlusal contact with opposing dentition.

Also known as: Conventional Loading

Conventional Loading Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-60 years;
• Gender: Male or Female;
• 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;
• Patients choosing the ITI implant system;
• Patients without a history of systemic diseases such as cardiovascular disease, hypertension, diabetes, etc.;
• Patients with no history of periodontal disease or have undergone periodontal treatment and can maintain good oral hygiene with no smoking history;
• Patients without a history of radiation therapy, hepatitis, tuberculosis, or any familial hereditary diseases;
• Patients with a normal anterior occlusion.

You may not qualify if:

• Patients with bone defects other than labial open-type single-wall bone defects in the anterior region;
• Patients with multiple consecutive missing upper anterior teeth;
• Patients with a history of systemic diseases, infectious diseases, or familial hereditary diseases;
• Patients with poor oral hygiene;
• Patients with bruxism or teeth clenching.

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Stomatology Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Yixun Chen

  Stomatology Hospital Affiliated to Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Entang Wang

CONTACT

13616719380; wet_email@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study takes a single-blind method. During research process, the researchers and paticipant cannot avoid knowing the time of loading during the clinical examination and operation, so the outcomes assessor can only be single-blinded.The clinical examination data were measured and averaged by two independent clinicians. The data was analysed by a third person.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: October 5, 2023
• Study Start: October 3, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)