Tooth LossNCT04559802
Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation
A study testing Transmucosal Technique and Submerged Technique in people with Tooth Loss, run by Nova Southeastern University at 1 site in United States.
Trial summary
It is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Transmucosal Technique and Submerged Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2020to 15 Feb 2024
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age more than 21 years - ASA I or II.
- Patient's willingness to participate in this study.
- Availability for 4-month follow-up.
- Absence of active periodontal disease.
- Single tooth replacement is needed with simultaneous contour augmentation.
- Available pre-operative CBCT study.
- Extraction of tooth at least 8 weeks prior to planned implant therapy.
Who cannot join
- Pregnancy at the screening visit.
- Smoking more than 10 cig/day.
- Active infection at the site of surgery (teeth involved).
- Multiple missing teeth adjacent to each other (long span edentulous area).
- Vertical bone defect less than 2mm (intra surgical assessment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Submerged Versus Non-Submerged Healing of Implants Subjected to Contour Augmentation.
It is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation.
Read the detailed description
Implants receiving Contour Augmentations at the time of placement are randomized into two groups, submerged and non submerged. Healing is evaluated at 4 months post op compared to the day of surgery.
- Conditions
- Tooth Loss
- Being tested
- Transmucosal Technique, Submerged Technique
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmucosal TechniqueProcedure or surgery
Also called Non-submerged technique
Dental implant will be placed in transmucosal manner (Healing abutment is exposed in the mouth).
Submerged TechniqueProcedure or surgery
Dental implant will be installed in submerged manner (implant is completed covered by soft tissue).
| Study group | Role | What they receive |
|---|---|---|
| Transmucosal (Non-Submerged) | Experimental | Flaps will be adapted to the healing abutments for a trans-mucosal healing up on closure Receives: Procedure: Transmucosal Technique |
| Submerged | Active comparator | Flaps will be advanced to achieve primary wound closure. Receives: Procedure: Submerged Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hard tissue healing around dental implants
bone healing around Submerged and Non-submerged dental implants will be measured by Periodontal probe and radiographs. A Mann-Whitney U Test will be used to calculate bone healing changes. To evaluate bone healing Mean values, standard deviations and frequencies will be calculated.
Measured: 4 months
Secondary outcomes (1)
Soft tissue healing around dental implants
Soft tissue healing around Submerged and Non-submerged dental implants. Fisher's exact test will be used to evaluate soft tissue healing changes through analyzing the measurements obtained by periodontal probe and radiographs.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start2 Oct 2020
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theofilos Koutouzis, Nova Southeastern University
- Investigators
- Stavros Sofos, DDS, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559802
- Sponsor's protocol ID
- 2020-341
- Status last verified
- Feb 2024
- First submitted
- 6 Sep 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submerged Versus Non-Submerged Healing of Implants Subjected to Contour Augmentation.
- ClinicalTrials.gov ID
- NCT04559802
- Acronym / sponsor ID
- 2020-341
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 23 Sep 2020 (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.
It is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation.
Detailed description
Implants receiving Contour Augmentations at the time of placement are randomized into two groups, submerged and non submerged. Healing is evaluated at 4 months post op compared to the day of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transmucosal (Non-Submerged) | Experimental | Procedure: Transmucosal TechniqueFlaps will be adapted to the healing abutments for a trans-mucosal healing up on closure |
| Submerged | Active comparator | Procedure: Submerged TechniqueFlaps will be advanced to achieve primary wound closure. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age more than 21 years - ASA I or II.
- Patient's willingness to participate in this study.
- Availability for 4-month follow-up.
- Absence of active periodontal disease.
- Single tooth replacement is needed with simultaneous contour augmentation.
Key exclusion criteria (5 listed)
- Pregnancy at the screening visit.
- Smoking more than 10 cig/day.
- Active infection at the site of surgery (teeth involved).
- Multiple missing teeth adjacent to each other (long span edentulous area).
- Vertical bone defect less than 2mm (intra surgical assessment)
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 |
|---|---|---|
| Transmucosal TechniqueAlso: Non-submerged techniqueDental implant will be placed in transmucosal manner (Healing abutment is exposed in the mouth). | Procedure or surgery | Transmucosal (Non-Submerged) |
| Submerged TechniqueDental implant will be installed in submerged manner (implant is completed covered by soft tissue). | Procedure or surgery | Submerged |
Primary outcome
Hard tissue healing around dental implants
Time frame: 4 months
bone healing around Submerged and Non-submerged dental implants will be measured by Periodontal probe and radiographs. A Mann-Whitney U Test will be used to calculate bone healing changes. To evaluate bone healing Mean values, standard deviations and frequencies will be calculated.
1 secondary outcome
Soft tissue healing around dental implants
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Stavros Sofos, DDS principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transmucosal Technique and Submerged Technique in people with Tooth Loss, run by Nova Southeastern University at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 20 Feb 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hard tissue healing around dental implants (time frame: 4 months). 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 20 Feb 2024.