EdentulousNCT02867982
Platform Switched Implant and Bone Level Alteration
A study testing Subcrestal implant placement, Paracrestal implant placement and prophylactic antibiotics in people with Edentulous and Bone Resorption, run by Beijing University Health Science Center.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous, Bone Resorption
- What is being tested?
- Subcrestal implant placement, Paracrestal implant placement and prophylactic antibiotics
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- medical and/or psychiatric contraindication to dental implant restoration
- local infection
- pregnancy or lactating
- poor oral hygiene
- tissue deficiency
About this study
Official title: Influence of Soft Tissue Thickness and Insertion Depth of Platform Switched Implants on Crestal Bone Level Alteration
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.
- Conditions
- Edentulous, Bone Resorption
- Being tested
- Subcrestal implant placement, Paracrestal implant placement, prophylactic antibiotics, dental implant, x-ray examination
- Keywords
- platform switching, crestal bone remodeling, soft tissue thickness, dental implant
- Medical subject headings
- Mouth, Edentulous, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcrestal implant placementProcedure or surgery
Dental implants placed 2 mm below the alveolar ridge
Paracrestal implant placementProcedure or surgery
Dental implants placed flush to the alveolar ridge
prophylactic antibioticsDrug
amoxicillin was used before and after implant surgery for prophylactic reasons
dental implantDevice
dental implants (Ankylos® system,Dentsply Implants Manufacturing GmbH, Mannheim, Germany) were surgically placed into the edentulous alveolar ridge
x-ray examinationRadiation
radiographies were taken before treatment and at different time point during the follow-up period
| Study group | Role | What they receive |
|---|---|---|
| Subcrestal | Other | implants that are placed below the alveolar ridge Receives: Procedure: Subcrestal implant placement; Drug: prophylactic antibiotics; Device: dental implant; Radiation: x-ray examination |
| Paracrestal | Other | implants that are placed flush to the alveolar ridge Receives: Procedure: Paracrestal implant placement; Drug: prophylactic antibiotics; Device: dental implant; Radiation: x-ray examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
Secondary outcomes (3)
Bleeding on probing(BOP)
bleeding index whiling probing the implant restorations
Measured: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
Probing pocket depth(PPD)
probing depth of implant supported restorations
Measured: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
modified plaque index(PI)
Modified plaque index to evaluate the oral hygiene conditions
Measured: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Jiang Xi, Beijing University Health Science Center
- Investigators
- Xi Jiang, DMD, Principal investigator, Peking University school and hospital of stomotology, Department of oral implantology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867982
- Sponsor's protocol ID
- I-AN-16-002
- Status last verified
- Aug 2016
- First submitted
- 24 Jul 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Soft Tissue Thickness and Insertion Depth of Platform Switched Implants on Crestal Bone Level Alteration
- ClinicalTrials.gov ID
- NCT02867982
- Acronym / sponsor ID
- I-AN-16-002
- Conditions
- Edentulous, Bone Resorption
- Keywords
- platform switching, crestal bone remodeling, soft tissue thickness, dental implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Beijing University Health Science CenterUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Jul 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcrestal | Other | Procedure: Subcrestal implant placement, Drug: prophylactic antibiotics, Device: dental implant, Radiation: x-ray examinationimplants that are placed below the alveolar ridge |
| Paracrestal | Other | Procedure: Paracrestal implant placement, Drug: prophylactic antibiotics, Device: dental implant, Radiation: x-ray examinationimplants that are placed flush to the alveolar ridge |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- medical and/or psychiatric contraindication to dental implant restoration
- local infection
- pregnancy or lactating
- poor oral hygiene
- tissue deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcrestal implant placementDental implants placed 2 mm below the alveolar ridge | Procedure or surgery | Subcrestal |
| Paracrestal implant placementDental implants placed flush to the alveolar ridge | Procedure or surgery | Paracrestal |
| prophylactic antibioticsamoxicillin was used before and after implant surgery for prophylactic reasons | Drug | Paracrestal, Subcrestal |
| dental implantdental implants (Ankylos® system,Dentsply Implants Manufacturing GmbH, Mannheim, Germany) were surgically placed into the edentulous alveolar ridge | Device | Paracrestal, Subcrestal |
| x-ray examinationradiographies were taken before treatment and at different time point during the follow-up period | Radiation | Paracrestal, Subcrestal |
Primary outcome
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.
3 secondary outcomes
Bleeding on probing(BOP)
Time frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
Probing pocket depth(PPD)
Time frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
modified plaque index(PI)
Time frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xi Jiang, DMD principal investigator
Peking University school and hospital of stomotology, Department of oral implantology
Questions about this trial
What is this clinical trial studying?
A study testing Subcrestal implant placement, Paracrestal implant placement and prophylactic antibiotics in people with Edentulous and Bone Resorption, run by Beijing University Health Science Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of marginal bone levels of dental implant (time frame: 3 months, 6 months, 1 year and 2 years post intervention (implant surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016; AzTrials last refreshed its copy on 29 Oct 2026.