Connective Tissue GraftNCT05194826
Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants
A study testing Test in people with Connective Tissue Graft and Anterior Aesthetic Zone, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate and compare the Vestibular Socket Therapy (VST) technique using fascia lata membrane versus connective tissue graft both with xenogenic lamina membrane in immediate implants of anterior aesthetic zone. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Connective Tissue Graft, Anterior Aesthetic Zone
- What is being tested?
- Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Mar 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Class II socket according to Elian et al, described as facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth in the maxillary anterior region.
- Thin gingival phenotype.
- Bone quality ranges from D2-D3 as gained from preoperative cone-beam computed tomography.
- Presence of at least 3 mm of keratinized gingiva.
- Optimal compliance as evidenced by no missing treatment appointments and a positive attitude towards oral hygiene
Who cannot join
- Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
- Smokers, diabetics, pregnant or lactating women.
- History of chemotherapy, radiotherapy in head and/or neck region.
- Bisphosphonate therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vestibular Socket Therapy Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants of Aesthetic Zone
The aim of this study is to evaluate and compare the Vestibular Socket Therapy (VST) technique using fascia lata membrane versus connective tissue graft both with xenogenic lamina membrane in immediate implants of anterior aesthetic zone.
- Conditions
- Connective Tissue Graft, Anterior Aesthetic Zone
- Being tested
- Test, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestProcedure or surgery
immediate implant and VST with fascia lata membrane + xenogenic lamina membrane and particulate bone graft composed of autogenous cortical chips harvested from the surgical site
ControlProcedure or surgery
immediate implant and VST with connective tissue graft + xenogenic lamina membrane and particulate bone graft composed of autogenous cortical chips harvested from the surgical site
| Study group | Role | What they receive |
|---|---|---|
| Fascia lata membrane | Experimental | Not described Receives: Procedure: Test |
| Connective tissue graft both with xenogenic lamina membrane | Active comparator | Not described Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peri-implant mucosal level
The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the changes in surface area calculated by software.
Measured: at baseline, 6 months and 12 months
Changes in gingival phenotype
The changes in gingival phenotype could be assessed at 6 months and 12 months intervals by superimposition of DICOM files on CBCT software.
Measured: at baseline, 6 months and 12 months
Chaneg in height of labial (facial) plate of bone
Cone beam computed tomography (CBCT)
Measured: at baseline, 6 months and 12 months
Chaneg in thickness of labial (facial) plate of bone
Cone beam computed tomography (CBCT)
Measured: at baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Jun 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue GraftStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194826
- Sponsor's protocol ID
- VST_21_22
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Socket Therapy Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants of Aesthetic Zone
- ClinicalTrials.gov ID
- NCT05194826
- Acronym / sponsor ID
- VST_21_22
- Conditions
- Connective Tissue Graft, Anterior Aesthetic Zone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 18 Jan 2022 (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 aim of this study is to evaluate and compare the Vestibular Socket Therapy (VST) technique using fascia lata membrane versus connective tissue graft both with xenogenic lamina membrane in immediate implants of anterior aesthetic zone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia lata membrane | Experimental | Procedure: Test |
| Connective tissue graft both with xenogenic lamina membrane | Active comparator | Procedure: Control |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Class II socket according to Elian et al, described as facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth in the maxillary anterior region.
- Thin gingival phenotype.
- Bone quality ranges from D2-D3 as gained from preoperative cone-beam computed tomography.
- Presence of at least 3 mm of keratinized gingiva.
- Optimal compliance as evidenced by no missing treatment appointments and a positive attitude towards oral hygiene
Key exclusion criteria (4 listed)
- Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
- Smokers, diabetics, pregnant or lactating women.
- History of chemotherapy, radiotherapy in head and/or neck region.
- Bisphosphonate 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 |
|---|---|---|
| Testimmediate implant and VST with fascia lata membrane + xenogenic lamina membrane and particulate bone graft composed of autogenous cortical chips harvested from the surgical site | Procedure or surgery | Fascia lata membrane |
| Controlimmediate implant and VST with connective tissue graft + xenogenic lamina membrane and particulate bone graft composed of autogenous cortical chips harvested from the surgical site | Procedure or surgery | Connective tissue graft both with xenogenic lamina membrane |
Primary outcome
Changes in peri-implant mucosal level
Time frame: at baseline, 6 months and 12 months
The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the changes in surface area calculated by software.
Changes in gingival phenotype
Time frame: at baseline, 6 months and 12 months
The changes in gingival phenotype could be assessed at 6 months and 12 months intervals by superimposition of DICOM files on CBCT software.
Chaneg in height of labial (facial) plate of bone
Time frame: at baseline, 6 months and 12 months
Cone beam computed tomography (CBCT)
Chaneg in thickness of labial (facial) plate of bone
Time frame: at baseline, 6 months and 12 months
Cone beam computed tomography (CBCT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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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.
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 Test in people with Connective Tissue Graft and Anterior Aesthetic Zone, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 4 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 18 Jan 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 Egypt. 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?
Changes in peri-implant mucosal level (time frame: at baseline, 6 months and 12 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 18 Jan 2022.