Gingival Recession (Miller II)NCT07717398
Evaluation of The Effect of Injectable Platelet-rich Fibrin With Collagen Membrane in Miller Class II Gingival Recession Coverage
A study testing Group (1) and Group 2 in people with Gingival Recession (Miller II), run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of injectable Platelet-Rich Fibrin (i-PRF) in combination with collagen membrane in the treatment of Miller Class II gingival recession. Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, which may lead to aesthetic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession (Miller II)
- What is being tested?
- Group (1) and Group 2
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Feb 2024to 12 Jan 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both males and females of age ≥ 18
Who cannot join
- History of systemic diseases (i.e. diabetes, autoimmune dysfunction, prolonged cortisone therapy, or chemotherapy) that contraindicated periodontal surgical treatment.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effect of injectable Platelet-Rich Fibrin (i-PRF) in combination with collagen membrane in the treatment of Miller Class II gingival recession. Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, which may lead to aesthetic concerns, root hypersensitivity, and increased risk of root caries.
The study will include patients diagnosed with Miller Class II gingival recession. Participants will be treated using a regenerative periodontal surgical approach involving coronally advanced flap combined with injectable platelet-rich fibrin and collagen membrane. Clinical parameters such as recession depth, clinical attachment level, and keratinized tissue width will be evaluated before and after treatment at specific follow-up intervals.
The objective is to compare the effectiveness of this combined regenerative approach in improving root coverage and soft tissue healing, and to assess its potential benefits in periodontal regeneration and esthetic outcomes.
- Conditions
- Gingival Recession (Miller II)
- Being tested
- Group (1), Group 2
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group (1)Procedure or surgery
Also called I-PRF+collagen membrane
Application of injectable platelet -rich fibrin (I-PRF) in combination with a collagen membrane during the surgical procedure to enhance soft and hard tissue healing
Group 2Procedure or surgery
Also called CAF+ SCTG
coronally advanced flap surgery combined with a subepithelial connective tissue graft for the treatment of gingival recession defects
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | i-PRF +collagen membrane Receives: Procedure: Group (1) |
| Group 2 | Active comparator | CAF+SCTG Receives: Procedure: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized Tissue Thickness
measured in millimeters (mm) using a endodontic file
Measured: Baseline, 1 month ,3 months and 6 months after surgery
Secondary outcomes (4)
Recession Depth (RD)
Measured: baseline,1 month,3 months,6 months after surgery
Recession Width (RW)
Measured: Baseline,1 month,3 months ,and 6 months after surgery
keratinized Tissue Height (KTH)
Measured: Baseline, 1 month, 3 months, 6 months after surgery
Probing Pocket Depth (PPD)
Measured: Baseline and 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 posted21 Jul 2026
- Study start24 Feb 2024
- Primary completion9 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession (Miller II)Studies of the same condition, open and under way.
- More trials run by Tanta 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ramadan Shawky Elsayed elazab, Tanta University
- Investigators
- Shereen Abdelmoula Ali, Principal investigator, Faculty of dentistry ,Tanta university .Tanta, Eygpt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717398
- Sponsor's protocol ID
- I_PRF with collagen membrane
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 28 Jul 2026
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Injectable Platelet-rich Fibrin With Collagen Membrane in Miller Class II Gingival Recession Coverage
- ClinicalTrials.gov ID
- NCT07717398
- Acronym / sponsor ID
- I_PRF with collagen membrane
- Conditions
- Gingival Recession (Miller II)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 21 Jul 2026 (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 aims to evaluate the effect of injectable Platelet-Rich Fibrin (i-PRF) in combination with collagen membrane in the treatment of Miller Class II gingival recession. Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, which may lead to aesthetic concerns, root hypersensitivity, and increased risk of root caries.
The study will include patients diagnosed with Miller Class II gingival recession. Participants will be treated using a regenerative periodontal surgical approach involving coronally advanced flap combined with injectable platelet-rich fibrin and collagen membrane. Clinical parameters such as recession depth, clinical attachment level, and keratinized tissue width will be evaluated before and after treatment at specific follow-up intervals.
The objective is to compare the effectiveness of this combined regenerative approach in improving root coverage and soft tissue healing, and to assess its potential benefits in periodontal regeneration and esthetic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Group (1)i-PRF +collagen membrane |
| Group 2 | Active comparator | Procedure: Group 2CAF+SCTG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Both males and females of age ≥ 18
Key exclusion criteria (1 listed)
- History of systemic diseases (i.e. diabetes, autoimmune dysfunction, prolonged cortisone therapy, or chemotherapy) that contraindicated periodontal surgical treatment.
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 |
|---|---|---|
| Group (1)Also: I-PRF+collagen membraneApplication of injectable platelet -rich fibrin (I-PRF) in combination with a collagen membrane during the surgical procedure to enhance soft and hard tissue healing | Procedure or surgery | Group 1 |
| Group 2Also: CAF+ SCTGcoronally advanced flap surgery combined with a subepithelial connective tissue graft for the treatment of gingival recession defects | Procedure or surgery | Group 2 |
Primary outcome
Keratinized Tissue Thickness
Time frame: Baseline, 1 month ,3 months and 6 months after surgery
measured in millimeters (mm) using a endodontic file
4 secondary outcomes
Recession Depth (RD)
Time frame: baseline,1 month,3 months,6 months after surgery
Recession Width (RW)
Time frame: Baseline,1 month,3 months ,and 6 months after surgery
keratinized Tissue Height (KTH)
Time frame: Baseline, 1 month, 3 months, 6 months after surgery
Probing Pocket Depth (PPD)
Time frame: Baseline and 6 months after surgery
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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.
Shereen Abdelmoula Ali principal investigator
Faculty of dentistry ,Tanta university .Tanta, Eygpt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group (1) and Group 2 in people with Gingival Recession (Miller II), run by Tanta 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 1 inclusion and 1 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 28 Jul 2026. 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?
Keratinized Tissue Thickness (time frame: Baseline, 1 month ,3 months and 6 months after surgery). 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 28 Jul 2026.