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Platform Switched Implant and Bone Level Alteration

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ClinicalTrials.gov Identifier: NCT02867982
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Jiang Xi, Beijing University Health Science Center

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.

Condition or disease Intervention/treatment Phase
Edentulous Bone Resorption Procedure: Subcrestal implant placement Procedure: Paracrestal implant placement Drug: prophylactic antibiotics Device: dental implant Radiation: x-ray examination Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Influence of Soft Tissue Thickness and Insertion Depth of Platform Switched Implants on Crestal Bone Level Alteration
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Subcrestal
implants that are placed below the alveolar ridge
Procedure: Subcrestal implant placement
Dental implants placed 2 mm below the alveolar ridge

Drug: prophylactic antibiotics
amoxicillin was used before and after implant surgery for prophylactic reasons

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

Radiation: x-ray examination
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
Procedure: Paracrestal implant placement
Dental implants placed flush to the alveolar ridge

Drug: prophylactic antibiotics
amoxicillin was used before and after implant surgery for prophylactic reasons

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

Radiation: x-ray examination
radiographies were taken before treatment and at different time point during the follow-up period




Primary Outcome Measures :
  1. Changes of marginal bone levels of dental implant [ Time Frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery) ]
    Mesial and distal marginal bone level alterations at different time point compared with the base line. Marginal bone levels were measured with an image analysis software to the accuracy of 0.01 mm and the implant length is used as calibration for the measurement.


Secondary Outcome Measures :
  1. Bleeding on probing(BOP) [ Time Frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery) ]
    bleeding index whiling probing the implant restorations

  2. Probing pocket depth(PPD) [ Time Frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery) ]
    probing depth of implant supported restorations

  3. modified plaque index(PI) [ Time Frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery) ]
    Modified plaque index to evaluate the oral hygiene conditions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867982


Sponsors and Collaborators
Beijing University Health Science Center
Dentsply Sirona Implants
Investigators
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Principal Investigator: Xi Jiang, DMD Peking University school and hospital of stomotology, Department of oral implantology

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Responsible Party: Jiang Xi, Dr., Beijing University Health Science Center
ClinicalTrials.gov Identifier: NCT02867982     History of Changes
Other Study ID Numbers: I-AN-16-002
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Jiang Xi, Beijing University Health Science Center:
platform switching
crestal bone remodeling
soft tissue thickness
dental implant

Additional relevant MeSH terms:
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Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Anti-Bacterial Agents
Anti-Infective Agents