Jaw, EdentulousNCT03806608
Evaluation of MBL Around Implants Placed in Crestal or Subcrestal Positions: a RCT
A study testing Crestal and Subcrestal in people with Jaw, Edentulous and Partial Edentulism, run by Sun Yat-sen University at 1 site in China.
Trial summary
The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partial Edentulism
- What is being tested?
- Crestal and Subcrestal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2019to May 2026
- 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
- Absence of 2-4 teeth in the posterior region of the maxilla or mandibular;
- Bone volume sufficient for implants with 4.1-mm size and 8- to 12-mm height and with no need for hard or soft tissue augmentation for implant treatment;
- Periodontally healthy.
Who cannot join
- Systemic diseases that may affect bone and soft tissue healing, such as diabetes, osteoporosis, Paget's disease, and patients with cancer;
- Uncontrolled periodontal disease or poor oral health with neither good nor adequate plaque control;
- Parafunctional habits, such as the grinding or clenching of teeth;
- Smoking habit (more than 10 cigarettes per day);
- Pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site
Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Clinical and Radiographic Evaluation of Marginal Bone Changes Around Platform-switching Implants Placed in Crestal or Subcrestal Positions: a Randomized Controlled Clinical Trial
The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest
Read the detailed description
The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest. Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant). Patients will be recalled for oral hygiene maintenance and prosthetic controls at 1year, 3 years, 5 years after final restoration.
- Conditions
- Jaw, Edentulous, Partial Edentulism
- Being tested
- Crestal, Subcrestal
- Keywords
- Marginal Bone Loss, Implant depth, Crestal or Subcrestal
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrestalProcedure or surgery
Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).
SubcrestalProcedure or surgery
Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).
| Study group | Role | What they receive |
|---|---|---|
| Crestal | Experimental | Implants were placed with the implant-abutment interface(IAI) at the level of the the alveolar ridge Receives: Procedure: Crestal |
| Subcrestal | Experimental | Implants were placed with the implant-abutment interface(IAI) 1 mm below the level of the alveolar ridge Receives: Procedure: Subcrestal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss(MBL)
Baseline will be recorded at the time of implantation. Margin bone loss(MBL) will be recorded at 0 day, 4 months, 1 year and 3 years after implant placement.
Measured: Change from baseline up to 5 years after implantation
Secondary outcomes (4)
Cumulative survival rate (CSR)
Cumulative survival rate will be assessed at final restoration, 1 year, 3 years, 5 years after final restoration
Measured: Up to 5 years after final restoration
Pocket probing depth (PPD)
Pocket probing depth will be assessed at 1 year, 3 years, 5 years after final restoration
Measured: Up to 5 years after final restoration
Plaque index (PI)
Plaque index will be assessed at 1 year, 3 years, 5 years after final restoration
Measured: Up to 5 years after final restoration
Bleeding on probing (BOP)
Bleeding on probing will be assessed at 1 year, 3 years, 5 years after final restoration
Measured: Up to 5 years after final restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start17 Apr 2019
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaw, EdentulousStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baoxin Huang, Sun Yat-sen University
- Investigators
- Baoxin Huang, PhD, Principal investigator, Sun Yat-sen Unniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806608
- Sponsor's protocol ID
- Baoxin Huang Depth
- Status last verified
- Apr 2022
- First submitted
- 14 Jan 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang B, Meng H, Zhu W, Witek L, Tovar N, Coelho PG. Influence of placement depth on bone remodeling around tapered internal connection implants: a histologic study in dogs. Clin Oral Implants Res. 2015 Aug;26(8):942-949. doi: 10.1111/clr.12384. Epub 2014 Apr 10.
PubMed 24720447Huang B, Meng H, Piao M, Xu L, Zhang L, Zhu W. Influence of placement depth on bone remodeling around tapered internal connection implant: a clinical and radiographic study in dogs. J Periodontol. 2012 Sep;83(9):1164-71. doi: 10.1902/jop.2012.110617. Epub 2012 Jan 5.
PubMed 22220773Koutouzis T, Neiva R, Nonhoff J, Lundgren T. Placement of implants with platform-switched Morse taper connections with the implant-abutment interface at different levels in relation to the alveolar crest: a short-term (1-year) randomized prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):1553-63. doi: 10.11607/jomi.3184.
PubMed 24278924Valles C, Rodriguez-Ciurana X, Clementini M, Baglivo M, Paniagua B, Nart J. Influence of subcrestal implant placement compared with equicrestal position on the peri-implant hard and soft tissues around platform-switched implants: a systematic review and meta-analysis. Clin Oral Investig. 2018 Mar;22(2):555-570. doi: 10.1007/s00784-017-2301-1. Epub 2018 Jan 8.
PubMed 29313133
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Marginal Bone Changes Around Platform-switching Implants Placed in Crestal or Subcrestal Positions: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03806608
- Acronym / sponsor ID
- Baoxin Huang Depth
- Conditions
- Jaw, Edentulous, Partial Edentulism
- Keywords
- Marginal Bone Loss, Implant depth, Crestal or Subcrestal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 16 Jan 2019 (actual)
- 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.
The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest
Detailed description
The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest. Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant). Patients will be recalled for oral hygiene maintenance and prosthetic controls at 1year, 3 years, 5 years after final restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crestal | Experimental | Procedure: CrestalImplants were placed with the implant-abutment interface(IAI) at the level of the the alveolar ridge |
| Subcrestal | Experimental | Procedure: SubcrestalImplants were placed with the implant-abutment interface(IAI) 1 mm below the level of the alveolar ridge |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Absence of 2-4 teeth in the posterior region of the maxilla or mandibular;
- Bone volume sufficient for implants with 4.1-mm size and 8- to 12-mm height and with no need for hard or soft tissue augmentation for implant treatment;
- Periodontally healthy.
Key exclusion criteria (5 listed)
- Systemic diseases that may affect bone and soft tissue healing, such as diabetes, osteoporosis, Paget's disease, and patients with cancer;
- Uncontrolled periodontal disease or poor oral health with neither good nor adequate plaque control;
- Parafunctional habits, such as the grinding or clenching of teeth;
- Smoking habit (more than 10 cigarettes per day);
- Pregnancy and breastfeeding.
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 |
|---|---|---|
| CrestalSubjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant). | Procedure or surgery | Crestal |
| SubcrestalSubjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant). | Procedure or surgery | Subcrestal |
Primary outcome
Marginal bone loss(MBL)
Time frame: Change from baseline up to 5 years after implantation
Baseline will be recorded at the time of implantation. Margin bone loss(MBL) will be recorded at 0 day, 4 months, 1 year and 3 years after implant placement.
4 secondary outcomes
Cumulative survival rate (CSR)
Time frame: Up to 5 years after final restoration
Pocket probing depth (PPD)
Time frame: Up to 5 years after final restoration
Plaque index (PI)
Time frame: Up to 5 years after final restoration
Bleeding on probing (BOP)
Time frame: Up to 5 years after final restoration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Background: PubMed 24720447Huang B, Meng H, Zhu W, Witek L, Tovar N, Coelho PG. Influence of placement depth on bone remodeling around tapered internal connection implants: a histologic study in dogs. Clin Oral Implants Res. 2015 Aug;26(8):942-949. doi: 10.1111/clr.12384. Epub 2014 Apr 10.
- Background: PubMed 22220773Huang B, Meng H, Piao M, Xu L, Zhang L, Zhu W. Influence of placement depth on bone remodeling around tapered internal connection implant: a clinical and radiographic study in dogs. J Periodontol. 2012 Sep;83(9):1164-71. doi: 10.1902/jop.2012.110617. Epub 2012 Jan 5.
- Background: PubMed 24278924Koutouzis T, Neiva R, Nonhoff J, Lundgren T. Placement of implants with platform-switched Morse taper connections with the implant-abutment interface at different levels in relation to the alveolar crest: a short-term (1-year) randomized prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):1553-63. doi: 10.11607/jomi.3184.
- Background: PubMed 29313133Valles C, Rodriguez-Ciurana X, Clementini M, Baglivo M, Paniagua B, Nart J. Influence of subcrestal implant placement compared with equicrestal position on the peri-implant hard and soft tissues around platform-switched implants: a systematic review and meta-analysis. Clin Oral Investig. 2018 Mar;22(2):555-570. doi: 10.1007/s00784-017-2301-1. Epub 2018 Jan 8.
- Individual participant dataSharing planned: Undecided
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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.
Baoxin Huang, PhD principal investigator
Sun Yat-sen Unniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crestal and Subcrestal in people with Jaw, Edentulous and Partial Edentulism, run by Sun Yat-sen University at 1 site in China.
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 3 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 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Marginal bone loss(MBL) (time frame: Change from baseline up to 5 years after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806608, which also lists 4 linked publications.
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 20 Apr 2022.