AllograftPhase 4NCT06219473
Efficacy of Fascia Lata Allograft and Platelet Rich Fibrin on the Periodontal Phenotype Around Dental Implant
A Phase 4 study testing Fascia lata membrane, Platlet Rich fibrin membrane and subepithelial connective tissue graft in people with Allograft, run by Kafrelsheikh University.
Trial summary
To compare between the efficacy of fascia lata allograft and platelet rich fibrin versus subepithelial connective tissue graft on periodontal phenotype (thickness and width of keratinized tissue, labial bone thickness) around dental implant in upper anterior region. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Allograft
- What is being tested?
- Fascia lata membrane, Platlet Rich fibrin membrane and subepithelial connective tissue graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Feb 2025
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with thin gingival biotype (gingival thickness was ≤1 mm)
- The height of keratinized gingiva for the site selected should be ≥2 mm.
- Ability to maintain good oral hygiene as evidenced in recall visits.
Who cannot join
- Smoker patient and pregnant or lactating woman.
- Patient with poor oral hygiene or active periodontal disease.
- Traumatic occlusion or para-functional habits such as clenching or bruxism.
- Patient with limited mouth opening
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Fascia Lata Allograft and Platelet Rich Fibrin Versus Connective Tissue Graft on the Periodontal Phenotype Around Dental Implant in Upper Anterior Region: A Randomized Controlled Clinical Trial
To compare between the efficacy of fascia lata allograft and platelet rich fibrin versus subepithelial connective tissue graft on periodontal phenotype (thickness and width of keratinized tissue, labial bone thickness) around dental implant in upper anterior region.
Read the detailed description
In order to evaluate the effectiveness of fascia lata allograft, platelet-rich fibrin, and subepithelial connective tissue graft on periodontal phenotype (including the thickness and width of keratinized tissue, as well as the thickness of labial bone) around dental implants in the upper anterior region, the purpose of this study is to compare the three types of grafts.
- Conditions
- Allograft
- Being tested
- Fascia lata membrane, Platlet Rich fibrin membrane, subepithelial connective tissue graft
- Keywords
- Fascia lata allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia lata membraneDrug
Also called Fascia lata allograft
novel allogenic derived acellular matrix produced from human fascia lata allograft
Platlet Rich fibrin membraneDrug
Also called Platlet Rich fibrin
Platelet-rich fibrin (PRF) or leukocyte- and platelet-rich fibrin (L-PRF) is a derivative of PRF where autologous platelets and leukocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue
subepithelial connective tissue graftDrug
Also called Connective tissue graft
The connective tissue is generally taken from the hard palate, although it may be taken from other sites as well, such as the maxillary tuberosity area.
| Study group | Role | What they receive |
|---|---|---|
| Fascia Lata (Study group) | Experimental | It includes eight patients seeking for implant placement in the upper anterior areas and implants will be placed with the application of fascia lata allograft membrane. Receives: Drug: Fascia lata membrane |
| PRF (Study group) | Experimental | It includes eight patients seeking for implant placement in the upper anterior area and implants will be placed with the application of PRF. Receives: Drug: Platlet Rich fibrin membrane |
| Connective tissue Graft(Control group) | Active comparator | It includes eight patients seeking for single implant placement at the upper anterior area and those patients will be received their implants with subepithelial connective tissue graft. Receives: Drug: subepithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink aesthetic score
Pink esthetic score The gingival response to a anterior esthetic evaluation is assessed by the Pink Esthetic Score (PES) from clinical photography
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllograftStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were classified into three main groups: Group 1 (Study group) It includes eight patients seeking for implant placement in the upper anterior areas and implants will be placed with the application of fascia lata allograft membrane. Group 2 (Study group) It includes eight patients seeking for implant placement in the upper anterior area and implants will be placed with the application of PRF. Group 3 (Control group) It includes eight patients seeking for single implant placement at the upper anterior area and those patients will be received their implants with subepithelial connective tissue graft.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Radwan Elhadidy, Kafrelsheikh University
- Investigators
- Enas elgendy, Prof, Study chair, Professor of Oral medicine and Periodontology at Kafr Elsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219473
- Sponsor's protocol ID
- KFSIRB200-87
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moraschini V, Kischinhevsky ICC, Sartoretto SC, Shibli JA, Dias AT, Sacco R, Yates J, Calasans-Maia MD. Is there any biomaterial substitute for peri-implant soft tissue phenotype modification? A network meta-analysis of the appraisal literature. Int J Oral Maxillofac Surg. 2022 Apr;51(4):526-534. doi: 10.1016/j.ijom.2021.07.005. Epub 2021 Aug 7.
PubMed 34373184
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fascia Lata Allograft and Platelet Rich Fibrin Versus Connective Tissue Graft on the Periodontal Phenotype Around Dental Implant in Upper Anterior Region: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06219473
- Acronym / sponsor ID
- KFSIRB200-87
- Conditions
- Allograft
- Keywords
- Fascia lata allograft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 23 Jan 2024 (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.
To compare between the efficacy of fascia lata allograft and platelet rich fibrin versus subepithelial connective tissue graft on periodontal phenotype (thickness and width of keratinized tissue, labial bone thickness) around dental implant in upper anterior region.
Detailed description
In order to evaluate the effectiveness of fascia lata allograft, platelet-rich fibrin, and subepithelial connective tissue graft on periodontal phenotype (including the thickness and width of keratinized tissue, as well as the thickness of labial bone) around dental implants in the upper anterior region, the purpose of this study is to compare the three types of grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients were classified into three main groups: Group 1 (Study group) It includes eight patients seeking for implant placement in the upper anterior areas and implants will be placed with the application of fascia lata allograft membrane. Group 2 (Study group) It includes eight patients seeking for implant placement in the upper anterior area and implants will be placed with the application of PRF. Group 3 (Control group) It includes eight patients seeking for single implant placement at the upper anterior area and those patients will be received their implants with subepithelial connective tissue graft.
| Arm | Type | Receives |
|---|---|---|
| Fascia Lata (Study group) | Experimental | Drug: Fascia lata membraneIt includes eight patients seeking for implant placement in the upper anterior areas and implants will be placed with the application of fascia lata allograft membrane. |
| PRF (Study group) | Experimental | Drug: Platlet Rich fibrin membraneIt includes eight patients seeking for implant placement in the upper anterior area and implants will be placed with the application of PRF. |
| Connective tissue Graft(Control group) | Active comparator | Drug: subepithelial connective tissue graftIt includes eight patients seeking for single implant placement at the upper anterior area and those patients will be received their implants with subepithelial connective tissue graft. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with thin gingival biotype (gingival thickness was ≤1 mm)
- The height of keratinized gingiva for the site selected should be ≥2 mm.
- Ability to maintain good oral hygiene as evidenced in recall visits.
Key exclusion criteria (4 listed)
- Smoker patient and pregnant or lactating woman.
- Patient with poor oral hygiene or active periodontal disease.
- Traumatic occlusion or para-functional habits such as clenching or bruxism.
- Patient with limited mouth opening
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 |
|---|---|---|
| Fascia lata membraneAlso: Fascia lata allograftnovel allogenic derived acellular matrix produced from human fascia lata allograft | Drug | Fascia Lata (Study group) |
| Platlet Rich fibrin membraneAlso: Platlet Rich fibrinPlatelet-rich fibrin (PRF) or leukocyte- and platelet-rich fibrin (L-PRF) is a derivative of PRF where autologous platelets and leukocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue | Drug | PRF (Study group) |
| subepithelial connective tissue graftAlso: Connective tissue graftThe connective tissue is generally taken from the hard palate, although it may be taken from other sites as well, such as the maxillary tuberosity area. | Drug | Connective tissue Graft(Control group) |
Primary outcome
Pink aesthetic score
Time frame: 6 Months
Pink esthetic score The gingival response to a anterior esthetic evaluation is assessed by the Pink Esthetic Score (PES) from clinical photography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 34373184Moraschini V, Kischinhevsky ICC, Sartoretto SC, Shibli JA, Dias AT, Sacco R, Yates J, Calasans-Maia MD. Is there any biomaterial substitute for peri-implant soft tissue phenotype modification? A network meta-analysis of the appraisal literature. Int J Oral Maxillofac Surg. 2022 Apr;51(4):526-534. doi: 10.1016/j.ijom.2021.07.005. Epub 2021 Aug 7.
- 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.
Enas elgendy, Prof study chair
Professor of Oral medicine and Periodontology at Kafr Elsheikh University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fascia lata membrane, Platlet Rich fibrin membrane and subepithelial connective tissue graft in people with Allograft, run by Kafrelsheikh University.
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 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmed Elhadidy, Msc (+201002698979, ahmed.elhadidyy.93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink aesthetic score (time frame: 6 Months). 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 NCT06219473, which also lists 1 linked publication.
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 23 Jan 2024.