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Status unknownNCT02867982Updated Aug 16, 2016

Platform Switched Implant and Bone Level Alteration

An interventional study of Subcrestal implant placement and Paracrestal implant placement in Edentulous and Bone Resorption, sponsored by Beijing University Health Science Center. Status unknown. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-16.

Sponsored by Beijing University Health Science Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Edentulous
  • Bone Resorption

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Keywords

  • platform switching
  • crestal bone remodeling
  • soft tissue thickness
  • dental implant
03

In context

Bone Resorption

153 studies on the registry are indexed under Bone Resorption; 25 are open to participants now.

This study's planned enrollment of 36 is above the median of 22 across 133 interventional studies indexed under Bone Resorption.

Browse Bone Resorption studies →

Lead sponsor

This is the only study on the registry with Beijing University Health Science Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • medical and/or psychiatric contraindication to dental implant restoration
  • local infection
  • pregnancy or lactating
  • poor oral hygiene
  • tissue deficiency
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Other
    Subcrestal

    implants that are placed below the alveolar ridge

    Procedure: Subcrestal implant placement · Drug: prophylactic antibiotics · Device: dental implant · Radiation: x-ray examination

  • Other
    Paracrestal

    implants that are placed flush to the alveolar ridge

    Procedure: Paracrestal implant placement · Drug: prophylactic antibiotics · Device: dental implant · Radiation: x-ray examination

Interventions

  • ProcedureSubcrestal implant placement

    Dental implants placed 2 mm below the alveolar ridge

  • ProcedureParacrestal implant placement

    Dental implants placed flush to the alveolar ridge

  • Drugprophylactic antibiotics

    amoxicillin was used before and after implant surgery for prophylactic reasons

  • Devicedental implant

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

  • Radiationx-ray examination

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

06

What researchers measure

Primary outcomes

  1. Changes of marginal bone levels of dental implant

    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.

    Time frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)

Secondary outcomes

  1. Bleeding on probing(BOP)

    bleeding index whiling probing the implant restorations

    Time frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)

  2. Probing pocket depth(PPD)

    probing depth of implant supported restorations

    Time frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)

  3. modified plaque index(PI)

    Modified plaque index to evaluate the oral hygiene conditions

    Time frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02867982
Lead sponsor
Beijing University Health Science Center
Collaborators
Dentsply Sirona Implants and Consumables
Responsible party
Jiang Xi (Dr., Beijing University Health Science Center) — Principal investigator
First posted
Aug 16, 2016
Start date
Jul 2016
Primary completion
Dec 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
Aug 16, 2016

Study contacts

Xi Jiang, DMD
principal investigator · Peking University school and hospital of stomotology, Department of oral implantology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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