Patients With at Least Single Missing Anterior ToothNCT03219944
Clinical Evaluation of Platelet Rich Fibrin Versus Subepithelial Connective Tissue Graft for Soft Tissue Augmentation
A study testing Platelet Rich Fibrin and sub epithelial connective tissue graft in people with Patients With at Least Single Missing Anterior Tooth and Thin Gingival Biotype, run by Cairo University at 1 site in Egypt.
Trial summary
Soft tissue biotype is a critical factor for success of implant in the esthetic zone . Different soft tissue augmentation techniques have been employed to increase soft tissue thickness such as: autogenous grafts, allografts, xenografts and living cellular construct (LCC). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With at Least Single Missing Anterior Tooth, Thin Gingival Biotype
- What is being tested?
- Platelet Rich Fibrin and sub epithelial connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2017to 1 Jan 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with missing maxillary anterior toot teeth.
- Thin gingival biotype.
- Adequate inter-arch space for placement of the implant prosthetic part.
- Good oral hygiene where gingival index is (0, 1) (Loe and Silness 1963).
Who cannot join
- Patient with medical condition that is contraindicated with the surgical procedure
- Patients receiving treatment that affect the healing ability.
- Patients with local pathological defects related to the area of interest.
- Smokers or pregnant women.
- Patients with parafunctional habits that may jeopardize the implant longevity and affect the results of the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Maymohamedkamal
Cairo, Elmaniel, 11311
may mo kamal, 01063392983, maykamalmo@gmail.com
About this study
Official title: Clinical Evaluation of Platelet Rich Fibrin Versus Subepithelial Connective Tissue Graft for Soft Tissue Augmentation Around Implant in the Aesthetic Zone: A Randomized Control Clinical Trial
Soft tissue biotype is a critical factor for success of implant in the esthetic zone . Different soft tissue augmentation techniques have been employed to increase soft tissue thickness such as: autogenous grafts, allografts, xenografts and living cellular construct (LCC). Studies showed that, allografts and xenografts were inferior when compared with autogenous graft . However, few studies were conducted to evaluate the efficacy of soft tissue augmentation with platelet rich fibrin in order to overcome the patient morbidity with SCTG.
- Being tested
- Platelet Rich Fibrin, sub epithelial connective tissue graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich FibrinProcedure or surgery
: Platelet Rich Fibrin for soft tissue augmentation around implant in the aesthetic zone
sub epithelial connective tissue graftProcedure or surgery
sub epithelial connective tissue graft for soft tissue augmentation around implant in the aesthetic zone
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Fibrin for soft tissue augmentation | Experimental | blood will be drawn from the patient vein for PRF. The blood sample will be centrifuged for 10-12 min. PRF membrane is obtained Receives: Procedure: Platelet Rich Fibrin |
| sub epithelial connective tissue graft | Active comparator | The connective tissue graft will be harvested from the palate. Then the SCTG will be placed over the recipient site extending palataly and sutured. Receives: Procedure: sub epithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone resorption
measured mesially and distally using periapical xray in mm
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 posted18 Jul 2017
- Study start15 Aug 2017 (estimated)
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With at Least Single Missing Anterior ToothStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, may mohamed kamal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219944
- Sponsor's protocol ID
- PERIODONTOLOGYcairo university
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 19 Jul 2017
- 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 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Platelet Rich Fibrin Versus Subepithelial Connective Tissue Graft for Soft Tissue Augmentation Around Implant in the Aesthetic Zone: A Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT03219944
- Acronym / sponsor ID
- PERIODONTOLOGYcairo university
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2017 (estimated)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Jan 2018 (estimated)
- First posted
- 18 Jul 2017 (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.
Soft tissue biotype is a critical factor for success of implant in the esthetic zone . Different soft tissue augmentation techniques have been employed to increase soft tissue thickness such as: autogenous grafts, allografts, xenografts and living cellular construct (LCC). Studies showed that, allografts and xenografts were inferior when compared with autogenous graft . However, few studies were conducted to evaluate the efficacy of soft tissue augmentation with platelet rich fibrin in order to overcome the patient morbidity with SCTG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Fibrin for soft tissue augmentation | Experimental | Procedure: Platelet Rich Fibrinblood will be drawn from the patient vein for PRF. The blood sample will be centrifuged for 10-12 min. PRF membrane is obtained |
| sub epithelial connective tissue graft | Active comparator | Procedure: sub epithelial connective tissue graftThe connective tissue graft will be harvested from the palate. Then the SCTG will be placed over the recipient site extending palataly and sutured. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with missing maxillary anterior toot teeth.
- Thin gingival biotype.
- Adequate inter-arch space for placement of the implant prosthetic part.
- Good oral hygiene where gingival index is (0, 1) (Loe and Silness 1963).
Key exclusion criteria (5 listed)
- Patient with medical condition that is contraindicated with the surgical procedure
- Patients receiving treatment that affect the healing ability.
- Patients with local pathological defects related to the area of interest.
- Smokers or pregnant women.
- Patients with parafunctional habits that may jeopardize the implant longevity and affect the results of the study.
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 |
|---|---|---|
| Platelet Rich Fibrin: Platelet Rich Fibrin for soft tissue augmentation around implant in the aesthetic zone | Procedure or surgery | Platelet Rich Fibrin for soft tissue augmentation |
| sub epithelial connective tissue graftsub epithelial connective tissue graft for soft tissue augmentation around implant in the aesthetic zone | Procedure or surgery | sub epithelial connective tissue graft |
Primary outcome
Crestal bone resorption
Time frame: 6 months
measured mesially and distally using periapical xray in mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Fibrin and sub epithelial connective tissue graft in people with Patients With at Least Single Missing Anterior Tooth and Thin Gingival Biotype, run by Cairo University 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 4 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 19 Jul 2017. 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?
Contact may mo kamal (01063392983, maykamalmo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal bone resorption (time frame: 6 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 19 Jul 2017.