HealthyNCT04356001
The "One-piece" Autologous Tuberosity Graft
A study testing Socket preservation in people with Healthy, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
A prospective study investigating clinically and radiologically the effectiveness of the use of a combined hard and soft tissue graft retrieved from the maxillary tuberosity and designed for alveolar ridge preservation following tooth extraction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Socket preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteLebanon
- Study dates
- 19 Jan 2019to 22 Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patient
- Patient with at least one single-rooted tooth to be extracted and be replaced with an implant
- No signs of acute infection : edema, suppuration, abscess, spontaneous bleeding
- Non-smoker or Light Smoker < 10 cigarettes/day
Who cannot join
- Pregnant or lactating females
- Non-controlled periodontal disease
- Medical conditions that contraindicate implant surgery
- Metabolic bone disorders such as osteoporosis,..
- Severe psychiatric conditions
- Heavy smoker > 10 cigarettes/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The "One-piece" Autologous Tuberosity Graft : a Novel Concept in Ridge Preservation
A prospective study investigating clinically and radiologically the effectiveness of the use of a combined hard and soft tissue graft retrieved from the maxillary tuberosity and designed for alveolar ridge preservation following tooth extraction.
Read the detailed description
Patients scheduled for a single mono-rooted tooth extraction are included in the study. After atraumatic extraction, sockets are filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine. CBCTs are performed before the extraction and 4 months after ridge preservation, to analyze the vertical and horizontal alterations of the ridge, using 'ITK-Snap' software.
Clinical measurements of both soft and hard tissues are also assessed during the extraction and implant placement.
- Conditions
- Healthy
- Being tested
- Socket preservation
- Keywords
- extraction, socket preservation, autologous, maxillary tuberosity, hard and soft tissue graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket preservationProcedure or surgery
Also called autologous tuberosity graft
'One-Piece' autologous tuberosity graft combining hard and soft tissue, harvested from the maxillary tuberosity, placed in extraction sockets.
| Study group | Role | What they receive |
|---|---|---|
| Socket preservation group | Experimental | Extraction sockets filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine. Receives: Procedure: Socket preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of volume of the ridge from baseline to 4 months post-op
Volumetric variation of the ridge, measured on superimposed images of CBCT.
Measured: 4 months
Change of Vertical dimension of the ridge from baseline to 4 months post-op
Linear Vertical variation of the ridge, measured on superimposed images of CBCT.
Measured: 4 months
Change of Horizontal dimension of the ridge from baseline to 4 months post-op
Linear Horizontal variation of the ridge at 3 different levels, measured on superimposed images of CBCT.
Measured: 4 months
Change in Soft tissue from baseline to 4 months post-op
Variation of the thickness of the buccal keratinized mucosa at 2 different levels, measured on superimposed images of CBCT.
Measured: 4 months
Secondary outcomes (3)
Change in buccal Soft tissue from baseline to 4 months post-op (clinical measurements)
Thickness of the keratinized mucosa on the buccal site, measured with a gauge caliper.
Measured: 4 months
Change in crestal Soft tissue from baseline to 4 months post-op (clinical measurements)
Thickness of the keratinized mucosa on the crestal site, measured with a gauge caliper.
Measured: 4 months
Change in Hard tissue from baseline to 4 months post-op (clinical measurements)
Horizontal dimension of the ridge (bucco-lingual) measured with a periodontal probe
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 posted21 Apr 2020
- Study start19 Jan 2019
- Primary completion1 Dec 2019
- Study completion22 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356001
- Sponsor's protocol ID
- USJ -2018-65
- Status last verified
- Apr 2020
- First submitted
- 6 Mar 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "One-piece" Autologous Tuberosity Graft : a Novel Concept in Ridge Preservation
- ClinicalTrials.gov ID
- NCT04356001
- Acronym / sponsor ID
- USJ -2018-65
- Conditions
- Healthy
- Keywords
- extraction, socket preservation, autologous, maxillary tuberosity, hard and soft tissue graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 22 Dec 2019 (actual)
- First posted
- 21 Apr 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.
A prospective study investigating clinically and radiologically the effectiveness of the use of a combined hard and soft tissue graft retrieved from the maxillary tuberosity and designed for alveolar ridge preservation following tooth extraction.
Detailed description
Patients scheduled for a single mono-rooted tooth extraction are included in the study. After atraumatic extraction, sockets are filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine. CBCTs are performed before the extraction and 4 months after ridge preservation, to analyze the vertical and horizontal alterations of the ridge, using 'ITK-Snap' software.
Clinical measurements of both soft and hard tissues are also assessed during the extraction and implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Socket preservation group | Experimental | Procedure: Socket preservationExtraction sockets filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy patient
- Patient with at least one single-rooted tooth to be extracted and be replaced with an implant
- No signs of acute infection : edema, suppuration, abscess, spontaneous bleeding
- Non-smoker or Light Smoker < 10 cigarettes/day
Key exclusion criteria (6 listed)
- Pregnant or lactating females
- Non-controlled periodontal disease
- Medical conditions that contraindicate implant surgery
- Metabolic bone disorders such as osteoporosis,..
- Severe psychiatric conditions
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 |
|---|---|---|
| Socket preservationAlso: autologous tuberosity graft'One-Piece' autologous tuberosity graft combining hard and soft tissue, harvested from the maxillary tuberosity, placed in extraction sockets. | Procedure or surgery | Socket preservation group |
Primary outcome
Change of volume of the ridge from baseline to 4 months post-op
Time frame: 4 months
Volumetric variation of the ridge, measured on superimposed images of CBCT.
Change of Vertical dimension of the ridge from baseline to 4 months post-op
Time frame: 4 months
Linear Vertical variation of the ridge, measured on superimposed images of CBCT.
Change of Horizontal dimension of the ridge from baseline to 4 months post-op
Time frame: 4 months
Linear Horizontal variation of the ridge at 3 different levels, measured on superimposed images of CBCT.
Change in Soft tissue from baseline to 4 months post-op
Time frame: 4 months
Variation of the thickness of the buccal keratinized mucosa at 2 different levels, measured on superimposed images of CBCT.
3 secondary outcomes
Change in buccal Soft tissue from baseline to 4 months post-op (clinical measurements)
Time frame: 4 months
Change in crestal Soft tissue from baseline to 4 months post-op (clinical measurements)
Time frame: 4 months
Change in Hard tissue from baseline to 4 months post-op (clinical measurements)
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 21 Apr 2020.
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket preservation in people with Healthy, run by Saint-Joseph University at 1 site in Lebanon.
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 4 inclusion and 6 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 21 Apr 2020. 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 Lebanon. 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?
Change of volume of the ridge from baseline to 4 months post-op (time frame: 4 months). The study lists 4 primary outcomes in all. 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 21 Apr 2020.