Alveolar Ridge AugmentationNCT05014763
Peri-implant Tissue Stability Following Tissue Augmentation Harvested From Deep Palate or Tuberosity
A study testing connective tissue graft in people with Alveolar Ridge Augmentation and Tissue Transplantation, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
This study will compare peri implant tissue stability following connective tissue graft harvested fromLateral Palate or the Tuberosity Area. As far as we know, it remains controversial whether peri-implant soft tissue stability could be achieved after soft tissue augmentation with the connective tissue graft from the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation, Tissue Transplantation, Tissue Donors
- What is being tested?
- connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIran
- Study dates
- 20 Sep 2021to 20 Dec 2022
- 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
- more than 18 years old.
- systemically and periodontally healthy patients.
- need of single implant placement between two maxillary teeth.
- need of tissue augmentation due to concavity or soft tissue thickness less than 2 millimetres .
- more than 3 month after extraction.
- full mouth plaque index lesser than 20%.
Show all 10Show fewer
- sufficient mesiodistal and buccolingual space.
- At least 10 millimetres mesiodistal dimension in tuberosity.
- sufficient implant primary stability.
- at least 6 mm crestal ridge width.
Who cannot join
- History of periodontitis and radiotherapy.
- Need of horizontal ridge augmentation.
- Previous soft tissue augmentation.
- Heavy smoker( more than 10 cigarette per day)
- Local or systemic conditions that would interfere with routine periodontal therapy.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tehran University of Medical Sciences
Tehran
Neda Moslemi, Periodontist, +982188492345, neda_moslemi@yahoo.com
Mohadeseh Heidari, Periodontist, 982188492345, heidari_mohadeseh@yahoo.com
About this study
Official title: Comparison of Peri-implant Tissue Stability Following Soft Tissue Augmentation Harvested From the Deep Palate or the Tuberosity Area: A Randomized Controlled Clinical Trial
This study will compare peri implant tissue stability following connective tissue graft harvested fromLateral Palate or the Tuberosity Area. As far as we know, it remains controversial whether peri-implant soft tissue stability could be achieved after soft tissue augmentation with the connective tissue graft from the tuberosity or the lateral palate. Soft tissue stability evaluated by intra oral scanner will be described as primary outcome.
Read the detailed description
Ridge resorption is a common finding after tooth extraction. Recently, there is an increasing concern about this issue during implant-supported reconstruction in the esthetic zone. Although the previous studies supports the guided bone regeneration procedures for reconstruction of contour deficiencies, the replacement of the mineralized materials with the bone has been questioned. Therefore, recently, using connective tissue grafts instead of allogenic or xenogenic materials has been addressed.
The palate is routinely used as the donor site for harvesting the connective tissue graft. The graft can be harvested by de-epithelialized method or it can be harvested conventionally from deep palate during flap elevation. Another choice for harvesting the connective tissue graft is the tuberosity area, which can be used when you need small to moderate amount of soft tissue (around 1-2 implants). The connective tissues harvested from these sites have quite different characteristics, which might influence on the fate of the treatment in terms of the stability.
therefore, we decided to compare the stability of the grafts harvested from the deep palate or tuberosity.
- Being tested
- connective tissue graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connective tissue graftProcedure or surgery
Connective tissue graft surgery will be done for increasing soft tissue volume. In this methods connective tissue will be harvested from lateral palate or tuberosity area.
| Study group | Role | What they receive |
|---|---|---|
| CTG from deep palate | Active comparator | The connective tissue graft harvested from the deep palate during flap elevation for implant placement Receives: Procedure: connective tissue graft |
| CTG from tuberosity | Experimental | The connective tissue graft harvested from the tuberosity Receives: Procedure: connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue volume change 0-3
changes of soft tissue volume from baseline (immediately before surgery) to 3 months by intra oral scanner
Measured: from baseline (immediately before surgery) to 3 months
soft tissue volume change 0-6
changes of soft tissue volume from baseline (immediately before surgery) to 6 months by intra oral scanner
Measured: from baseline (immediately before surgery) to 6 months
soft tissue volume change 3-6
changes of soft tissue volume from 3 months to 6 months by intra oral scanner
Measured: from 3 months to 6 months
Secondary outcomes (11)
The level of the pain by questionnaire through visual analogue scale
evaluation of the level of the pain by questionnaire through visual analogue scale method
Measured: immediately after surgery
The level of the pain by questionnaire through visual analogue scale
evaluation of the level of the pain by questionnaire through visual analogue scale method
Measured: day 1
The level of the pain by questionnaire through visual analogue scale
evaluation of the level of the pain by questionnaire through visual analogue scale method
Measured: day 2
The level of the pain by questionnaire through visual analogue scale
evaluation of the level of the pain by questionnaire through visual analogue scale method
Measured: day 3
The level of the pain by questionnaire through visual analogue scale
evaluation of the level of the pain by questionnaire through visual analogue scale method
Measured: day 4
The level of the pain by questionnaire through visual analogue scale
evaluation of the level of the pain by questionnaire through visual analogue scale method
Measured: day 5
The level of the pain by questionnaire through visual analogue scale
evaluation of the level of the pain by questionnaire through visual analogue scale method
Measured: day 6
The level of the pain by questionnaire through visual analogue scale
evaluation of the level of the pain by questionnaire through visual analogue scale method
Measured: day 7
Palliative 0-7
the number of palliatives the patient used during the first week after surgery
Measured: immediately after surgery to 7 days later
Pink aesthetic score
evaluation of the aesthetic score by photography
Measured: 3 months after surgery
Pink aesthetic score
evaluation of the aesthetic score by photography
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start20 Sep 2021 (estimated)
- Primary completion20 Sep 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AugmentationStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neda Moslemi, Periodontist, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014763
- Sponsor's protocol ID
- 9811213001
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- 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 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peri-implant Tissue Stability Following Soft Tissue Augmentation Harvested From the Deep Palate or the Tuberosity Area: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05014763
- Acronym / sponsor ID
- 9811213001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 20 Aug 2021 (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.
This study will compare peri implant tissue stability following connective tissue graft harvested fromLateral Palate or the Tuberosity Area. As far as we know, it remains controversial whether peri-implant soft tissue stability could be achieved after soft tissue augmentation with the connective tissue graft from the tuberosity or the lateral palate. Soft tissue stability evaluated by intra oral scanner will be described as primary outcome.
Detailed description
Ridge resorption is a common finding after tooth extraction. Recently, there is an increasing concern about this issue during implant-supported reconstruction in the esthetic zone. Although the previous studies supports the guided bone regeneration procedures for reconstruction of contour deficiencies, the replacement of the mineralized materials with the bone has been questioned. Therefore, recently, using connective tissue grafts instead of allogenic or xenogenic materials has been addressed.
The palate is routinely used as the donor site for harvesting the connective tissue graft. The graft can be harvested by de-epithelialized method or it can be harvested conventionally from deep palate during flap elevation. Another choice for harvesting the connective tissue graft is the tuberosity area, which can be used when you need small to moderate amount of soft tissue (around 1-2 implants). The connective tissues harvested from these sites have quite different characteristics, which might influence on the fate of the treatment in terms of the stability.
therefore, we decided to compare the stability of the grafts harvested from the deep palate or tuberosity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTG from deep palate | Active comparator | Procedure: connective tissue graftThe connective tissue graft harvested from the deep palate during flap elevation for implant placement |
| CTG from tuberosity | Experimental | Procedure: connective tissue graftThe connective tissue graft harvested from the tuberosity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- more than 18 years old.
- systemically and periodontally healthy patients.
- need of single implant placement between two maxillary teeth.
- need of tissue augmentation due to concavity or soft tissue thickness less than 2 millimetres .
- more than 3 month after extraction.
Key exclusion criteria (5 listed)
- History of periodontitis and radiotherapy.
- Need of horizontal ridge augmentation.
- Previous soft tissue augmentation.
- Heavy smoker( more than 10 cigarette per day)
- Local or systemic conditions that would interfere with routine periodontal therapy.
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 |
|---|---|---|
| connective tissue graftConnective tissue graft surgery will be done for increasing soft tissue volume. In this methods connective tissue will be harvested from lateral palate or tuberosity area. | Procedure or surgery | CTG from deep palate, CTG from tuberosity |
Primary outcome
soft tissue volume change 0-3
Time frame: from baseline (immediately before surgery) to 3 months
changes of soft tissue volume from baseline (immediately before surgery) to 3 months by intra oral scanner
soft tissue volume change 0-6
Time frame: from baseline (immediately before surgery) to 6 months
changes of soft tissue volume from baseline (immediately before surgery) to 6 months by intra oral scanner
soft tissue volume change 3-6
Time frame: from 3 months to 6 months
changes of soft tissue volume from 3 months to 6 months by intra oral scanner
11 secondary outcomes
The level of the pain by questionnaire through visual analogue scale
Time frame: immediately after surgery
The level of the pain by questionnaire through visual analogue scale
Time frame: day 1
The level of the pain by questionnaire through visual analogue scale
Time frame: day 2
The level of the pain by questionnaire through visual analogue scale
Time frame: day 3
The level of the pain by questionnaire through visual analogue scale
Time frame: day 4
The level of the pain by questionnaire through visual analogue scale
Time frame: day 5
The level of the pain by questionnaire through visual analogue scale
Time frame: day 6
The level of the pain by questionnaire through visual analogue scale
Time frame: day 7
Palliative 0-7
Time frame: immediately after surgery to 7 days later
Pink aesthetic score
Time frame: 3 months after surgery
Pink aesthetic score
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Alveolar Ridge Augmentation
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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.
Neda Moslemi, Periodontist principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing connective tissue graft in people with Alveolar Ridge Augmentation and Tissue Transplantation, run by Tehran University of Medical Sciences at 1 site in Iran.
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 10 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 Aug 2021. 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 Iran. 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?
Contact Neda Moslemi, Periodontist (+989128985838, neda_moslemi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soft tissue volume change 0-3 (time frame: from baseline (immediately before surgery) to 3 months). The study lists 3 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 20 Aug 2021.