Gingival RecessionNCT06621433
Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession
A study testing T-PRF with CAF and SECTG with CAF in people with Gingival Recession, run by Rizk Beshir at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the effectiveness of using titanium prepared platelet rich fibrin with coronally advanced flap in the treatment of type-2 Cairo gingival recession. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- T-PRF with CAF and SECTG with CAF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 22 Jan 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Gingival recession type 2 according to Cairo et al (2011).
- Adequate amount of Attached Gingiva (AG) (2 mm≤ AG).
- Good oral hygiene (full mouth bleeding score and O'Leary index less than ≤10 % after complete phase I therapy)
- Clinically thick gingival biotype (1mm \< gingival thickness).
- Anterior esthetic zone.
Who cannot join
- Patients with gingival recession types 1 and 3 according to Cairo et al.
- Inadequate amount of attached gingiva (AG \< 2 mm).
- Uncooperative patients.
- Smoking more than 10 cigarettes per day.
- Patients with known systemic conditions or taking medications that may affect soft tissue healing.
- Pregnant and lactating women.
- Patients with parafunctional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession: a Randomized Controlled Clinical Trial
The aim of the study is to evaluate the effectiveness of using titanium prepared platelet rich fibrin with coronally advanced flap in the treatment of type-2 Cairo gingival recession.
- Conditions
- Gingival Recession
- Being tested
- T-PRF with CAF, SECTG with CAF
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-PRF with CAFOther
Blood sample will be obtained from the patient, conveyed into a titanium tube and immediately centrifuged at 2700 rpm for 12 mins at room temperature using fixed angle centrifuge (PRF Process, Tangkula800-1, China). The fibrin clot will be collected and placed in the PRF compression device (PRF GRF box) and condensed to produce a uniform T-PRF membrane which will be inserted over the recession area and covered by the coronally advanced flap.
SECTG with CAFOther
Sub epithelial connective tissue graft will be obtained from the donor site (hard palate), placed into recipient site and secured by sutures, then covered by a coronally advanced flap.
| Study group | Role | What they receive |
|---|---|---|
| Coronally advanced flap (CAF) in conjunction with titanium prepared PRF | Experimental | Not described Receives: Other: T-PRF with CAF |
| CAF in conjunction with subepithelial connective tissue graft (SECTG) | Active comparator | Not described Receives: Other: SECTG with CAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
The distance from the base of the pocket to the most apical point on the gingival margin will be measured using a periodontal probe.
Measured: up to 6 months
Clinical attachment loss
Distance from the cement-enamel junction to the base of the periodontal pocket will be measured using a periodontal probe
Measured: up to 6 months
Recession width (RW)
Recession width (W) measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth) using a periodontal probe
Measured: up to 6 months
Recession height (RH)
It will be measured from the cementoenamel junction to the Gingival Margin (GM), parallel to the long axis of the tooth starting from the most apical point of the recession using a William's graduated periodontal probe
Measured: up to 6 months
Width of keratinized gingiva (KT)
Width of keratinized gingiva will be measured as the distance from the gingival margin to the mucogingival junction
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Jan 2023
- Primary completion20 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies 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
- Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rizk Beshir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rizk Beshir, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621433
- Sponsor's protocol ID
- 1/1-2023
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06621433
- Acronym / sponsor ID
- 1/1-2023
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rizk BeshirUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 1 Oct 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.
The aim of the study is to evaluate the effectiveness of using titanium prepared platelet rich fibrin with coronally advanced flap in the treatment of type-2 Cairo gingival recession.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronally advanced flap (CAF) in conjunction with titanium prepared PRF | Experimental | Other: T-PRF with CAF |
| CAF in conjunction with subepithelial connective tissue graft (SECTG) | Active comparator | Other: SECTG with CAF |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gingival recession type 2 according to Cairo et al (2011).
- Adequate amount of Attached Gingiva (AG) (2 mm≤ AG).
- Good oral hygiene (full mouth bleeding score and O'Leary index less than ≤10 % after complete phase I therapy)
- Clinically thick gingival biotype (1mm \< gingival thickness).
- Anterior esthetic zone.
Key exclusion criteria (7 listed)
- Patients with gingival recession types 1 and 3 according to Cairo et al.
- Inadequate amount of attached gingiva (AG \< 2 mm).
- Uncooperative patients.
- Smoking more than 10 cigarettes per day.
- Patients with known systemic conditions or taking medications that may affect soft tissue healing.
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 |
|---|---|---|
| T-PRF with CAFBlood sample will be obtained from the patient, conveyed into a titanium tube and immediately centrifuged at 2700 rpm for 12 mins at room temperature using fixed angle centrifuge (PRF Process, Tangkula800-1, China). The fibrin clot will be collected and placed in the PRF compression device (PRF GRF box) and condensed to produce a uniform T-PRF membrane which will be inserted over the recession area and covered by the coronally advanced flap. | Other | Coronally advanced flap (CAF) in conjunction with titanium prepared PRF |
| SECTG with CAFSub epithelial connective tissue graft will be obtained from the donor site (hard palate), placed into recipient site and secured by sutures, then covered by a coronally advanced flap. | Other | CAF in conjunction with subepithelial connective tissue graft (SECTG) |
Primary outcome
Probing depth
Time frame: up to 6 months
The distance from the base of the pocket to the most apical point on the gingival margin will be measured using a periodontal probe.
Clinical attachment loss
Time frame: up to 6 months
Distance from the cement-enamel junction to the base of the periodontal pocket will be measured using a periodontal probe
Recession width (RW)
Time frame: up to 6 months
Recession width (W) measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth) using a periodontal probe
Recession height (RH)
Time frame: up to 6 months
It will be measured from the cementoenamel junction to the Gingival Margin (GM), parallel to the long axis of the tooth starting from the most apical point of the recession using a William's graduated periodontal probe
Width of keratinized gingiva (KT)
Time frame: up to 6 months
Width of keratinized gingiva will be measured as the distance from the gingival margin to the mucogingival junction
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 1 Oct 2024.
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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 T-PRF with CAF and SECTG with CAF in people with Gingival Recession, run by Rizk Beshir 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 7 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 1 Oct 2024. 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?
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?
Probing depth (time frame: up to 6 months). The study lists 5 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 1 Oct 2024.