Platform Switched Implant and Bone Level Alteration

NCT ID: NCT02867982

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-12-31

Brief Summary

This is a two-year prospective randomized clinical study to to evaluate whether the gingival thickness and insertion depth of dental implants have any influence on marginal bone levels changes around platform switched implants.

Detailed Description

Patient selection: Patients at the Department of Oral Implantology, Peking University School and Hospital of stomatology, Bei Jing, China, who seek for implant restoration for two continous posterior teeth are potentially recruited. Inclusion criteria are generally healthy (ASA score I), non-smoking, periodontally healthy, and sufficient bone volume to place an implant without augmentation procedure. Patients were excluded in cases of medical and/or psychiatric contraindications, local infection, pregnancy or lactating, poor oral hygiene, tissue deficiency, or not willing to participate in this study.

Randomization: The two implant sites of each subject are randomly assigned to two different group with a predefined randomization tables. In order to reduce the chance of unfavorable splits between groups in terms of key prognostic factors,the randomization process will take into account the following variables: patient's gender, age, presence of adjacent teeth, distal extension sites and site location in the dental arch. Assignment will perform using a sealed envelope.

Surgical protocol: Before the surgical procedure, prophylactic antibiotics of 1g amoxicillin will prescribed to the patient 1 h before surgery, and continued with 2 g/day for 6 days. After crestal incision, full thickness buccal flap was raised, whereas lingual part was not elevated. Thickness of soft tissues was measured with 1.0-mm marked periodontal probe on the top of bone crest in the center of the two future implant sites. This ensured direct visibility of mucosal thickness during measurement. After measurements, full-thickness lingual flap is raised and subsequent implant osteotomy is finished, Two dental implants (Dentsply Implants Manufacturing GmbH, Mannheim, Germany) with diameter of 3.5 mm are ready to torch into the bone cavities. In one site (group 1), the platform of implants are placed at the crestal level (flush to the alveolar ridge) . In the other site (group 2), the implants are placed 1mm below the alveolar ridge. narrow healing abutment are connected to all the implants. The flap are repositioned and closed with interrupted single sutures. Implants are allowed for a un-submerged healing. 3 month after healing, the implant level impressions are taken, splinted restorations of two neighbouring posterior teeth are delivered 2 weeks later.

Radiographic and Clinical Examination: All the patients are required for recall visit at 3, 6,12 months and 2 years post surgery. A digital peri-apical radiograph was taken at the 1 year and 2year follow-up examination for bone level evaluation using a film holder to aim the x-ray beam perpendicular to the implant threads, and the implant length is used as calibration for the measurement. Using a image analysis software (ImageJ, version 1.47, NIH, Bethesda, MD, USA), the investigators are able to have an accurate assessment of the crest of bone and to analyze the bone changes over period of time. Bone loss was defined as a positive value and bone gain as a negative one. Mean values, standard deviations, and maximum and minimum values were calculated. Furthermore, periodontal parameters [bleeding on probing (BOP), probing pocket depth (PPD), modified plaque index on adjacent teeth and implants] were assessed.

Conditions

Edentulous; Bone Resorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Subcrestal

implants that are placed below the alveolar ridge

Group Type: OTHER

Subcrestal implant placement

Intervention Type: PROCEDURE

Dental implants placed 2 mm below the alveolar ridge

prophylactic antibiotics

Intervention Type: DRUG

amoxicillin was used before and after implant surgery for prophylactic reasons

dental implant

Intervention Type: DEVICE

dental implants (Ankylos® system,Dentsply Implants Manufacturing GmbH, Mannheim, Germany) were surgically placed into the edentulous alveolar ridge

x-ray examination

Intervention Type: RADIATION

radiographies were taken before treatment and at different time point during the follow-up period

Paracrestal

implants that are placed flush to the alveolar ridge

Group Type: OTHER

Paracrestal implant placement

Intervention Type: PROCEDURE

Dental implants placed flush to the alveolar ridge

prophylactic antibiotics

Intervention Type: DRUG

amoxicillin was used before and after implant surgery for prophylactic reasons

dental implant

Intervention Type: DEVICE

dental implants (Ankylos® system,Dentsply Implants Manufacturing GmbH, Mannheim, Germany) were surgically placed into the edentulous alveolar ridge

x-ray examination

Intervention Type: RADIATION

radiographies were taken before treatment and at different time point during the follow-up period

Interventions

Subcrestal implant placement

Dental implants placed 2 mm below the alveolar ridge

Intervention Type: PROCEDURE

Paracrestal implant placement

Dental implants placed flush to the alveolar ridge

Intervention Type: PROCEDURE

prophylactic antibiotics

amoxicillin was used before and after implant surgery for prophylactic reasons

Intervention Type: DRUG

dental implant

dental implants (Ankylos® system,Dentsply Implants Manufacturing GmbH, Mannheim, Germany) were surgically placed into the edentulous alveolar ridge

Intervention Type: DEVICE

x-ray examination

radiographies were taken before treatment and at different time point during the follow-up period

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• lose of two posterior teeth more than 3 months
• generally healthy (ASA score I)
• non-smoking
• periodontally healthy
• sufficient bone volume to place an implant without augmentation procedure

Exclusion Criteria

• medical and/or psychiatric contraindication to dental implant restoration
• local infection
• pregnancy or lactating
• poor oral hygiene
• tissue deficiency

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: collaborator

Beijing University Health Science Center

OTHER

Sponsor Role: lead

Responsible Party

Jiang Xi

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xi Jiang, DMD

Role: PRINCIPAL_INVESTIGATOR

Peking University school and hospital of stomotology, Department of oral implantology

Other Identifiers

I-AN-16-002

Identifier Type: -

Identifier Source: org_study_id