Gingival RecessionNCT06646432
Treatment of Gingival Recession With Tunnel Technique Using Connective Tissue Graft and Injectable Platelet Rich Fibrin
A study testing Tunnel with connective tissue graft and injectable platelet rich fibrin and Tunnel with connective tissue graft only in people with Gingival Recession, run by Suez Canal University at 1 site in Egypt.
Trial summary
Gingival recession is a common periodontal problem. Consequences include teeth sensitivity, poor esthetics and impaired oral hygiene access. Mild cases are managed by optimizing oral hygiene measures, correction of any causative factor such as faulty tooth brushing, improper dental restoration or denture clasp. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Tunnel with connective tissue graft and injectable platelet rich fibrin and Tunnel with connective tissue graft only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 21 years old
- Systemically healthy
- Presence of Miller class I/II gingival recession
- Presence of identifiable CEJ
Who cannot join
- Smoking
- Systemic disease that contraindicates surgical procedures.
- Poor compliance with oral hygiene measures
- Necrotizing gingival conditions
- Ongoing active periodontitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, Suez canal university
Ismailia, 41522
Abdelaziz, 002+ 01118580817, mohamed_naser@dent.suez.edu.eg
About this study
Official title: Treatment of Gingival Recession by Tunnel Technique Using Connective Tissue Graft With or Without Injectable Platelet Rich Fibrin: A Randomized Controlled Clinical Trial
Gingival recession is a common periodontal problem. Consequences include teeth sensitivity, poor esthetics and impaired oral hygiene access. Mild cases are managed by optimizing oral hygiene measures, correction of any causative factor such as faulty tooth brushing, improper dental restoration or denture clasp. Prescription of desensitization products such as specific tooth gels or mouth washes can manage the sensitivity problem. Deeper recession defects need to be addressed by surgical procedures. Coronally advanced flap with connective tissue graft is the gold standard procedure. However, it has some drawbacks due to the need for papillary incisions and vertical incisions in some cases. Within the era of minimally invasive periodontology, tunnel technique with connective tissue graft showed results comparable to coronally advanced flap with connective tissue graft but with some limitations. Addition of another agent may enhance the results of tunnel technique. Injectable platelet rich fibrin is known for its content of growth factors and effects on soft tissue healing. Aim: The study aim is to compare the surgical management of gingival recession with tunnel technique using connective tissue graft and injectable platelet rich fibrin to tunnel with connective graft without injectable platelet rich fibrin.
Methodology: 30 patients with miller class I or II gingival recession will be enrolled. 15 in the test group (Tunnel+ CTG+ i-PRF) and 15 in control group (Tunnel+ CTG). Clinical evaluation at 6 months
Read the detailed description
30 patients with miller class I/II gingival recession will be enrolled in this study.
15 patients will be treated using tunnel technique and palatal connective tissue graft inserted and sutured under the prepared tunnel after being soaked in injectable platelet rich fibrin for 15 minutes. The tunnel with the underlying graft will be advanced coronally. (Test Group) The other 15 patients will be treated the same way as in the first group but without soaking the graft in injectable platelet rich fibrin. (Control Group) Clinical parameters will be evaluated at baseline and 6 months follow-up except post-operative pain which will be assessed after 10 days. Histologic examination of small piece of the graft will be done to assess if there is true saturation of growth factors inside the graft.
- Conditions
- Gingival Recession
- Being tested
- Tunnel with connective tissue graft and injectable platelet rich fibrin, Tunnel with connective tissue graft only
- Keywords
- Tunneling, Gingival recession, Injectable platelet rich fibrin, Minimally invasive periodontology
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunnel with connective tissue graft and injectable platelet rich fibrinProcedure or surgery
Tunnel with connective tissue graft and injectable platelet rich fibrin
Tunnel with connective tissue graft onlyProcedure or surgery
Tunnel technique with connective tossue graft only without injectable platelet rich fibrin
| Study group | Role | What they receive |
|---|---|---|
| Test group: tunnel with connective tissue graft and injectable platelet rich fibrin | Experimental | Tunneling will be performed at the recession defect sites with insertion of palatal connective tissue graft taken from the patient hard palate inside the prepared tunnel. The graft will be soaked ,before insertion inside the tunnel, in injectable platelet rich fibrin ,prepared from patient own blood for 15 minutes. The tunnel with the soaked graft inside will be advanced coronally. Receives: Procedure: Tunnel with connective tissue graft and injectable platelet rich fibrin |
| Control group: tunnel with connective tissue graft only | Active comparator | Tunnel preparation will be made in the recession defect sites with insertion of palatal connective tissue graft from the patient hard palate. The tunnel with the graft will be advanced coronally. Receives: Procedure: Tunnel with connective tissue graft only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession depth
it will be recorded as the distance between the CEJ and gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.
Measured: 6 months after the surgery
Keratinized tissue height
It will be measured from the mucogingival junction to the gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.
Measured: 6 months
Gingival thickness
It will be measured at a mid-buccal location 1 mm apical to the probing depth level with an spreader. It will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface. Penetration depth will be measured.
Measured: 6 months
Secondary outcomes (2)
Post operative pain
It will be measured by Visual analog Scale (VAS) with records from 0 to 10 with 0 means no pain and 10 means very severe pain. The patient will report the degree he experienced pain and choose a score from VAS.
Measured: 10 days
Recession width
It will be measured horizontally between the borders of the recession at the level of Cemento-enamel Junction.
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 posted17 Oct 2024
- Study start1 Nov 2024
- Primary completionJun 2025 (estimated)
- Study completionSep 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 Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdelnasser Elrefaey, Study chair, Suez Canal UniversityShaimaa Morsy, Study director, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646432
- Sponsor's protocol ID
- 486/2022
- Status last verified
- Jan 2025
- First submitted
- 3 Oct 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahmoud MNA, Elrefaei AMH, Shata MS, Rokaya D, Morsy SM. Connective tissue graft with injectable platelet rich fibrin for treatment of RT1 gingival recession by tunnel technique: a randomized clinical and immunohistochemical study. Front Oral Health. 2026 Jun 10;7:1801423. doi: 10.3389/froh.2026.1801423. eCollection 2026.
PubMed 42359019
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Gingival Recession by Tunnel Technique Using Connective Tissue Graft With or Without Injectable Platelet Rich Fibrin: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06646432
- Acronym / sponsor ID
- 486/2022
- Conditions
- Gingival Recession
- Keywords
- Tunneling, Gingival recession, Injectable platelet rich fibrin, Minimally invasive periodontology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 17 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.
Gingival recession is a common periodontal problem. Consequences include teeth sensitivity, poor esthetics and impaired oral hygiene access. Mild cases are managed by optimizing oral hygiene measures, correction of any causative factor such as faulty tooth brushing, improper dental restoration or denture clasp. Prescription of desensitization products such as specific tooth gels or mouth washes can manage the sensitivity problem. Deeper recession defects need to be addressed by surgical procedures. Coronally advanced flap with connective tissue graft is the gold standard procedure. However, it has some drawbacks due to the need for papillary incisions and vertical incisions in some cases. Within the era of minimally invasive periodontology, tunnel technique with connective tissue graft showed results comparable to coronally advanced flap with connective tissue graft but with some limitations. Addition of another agent may enhance the results of tunnel technique. Injectable platelet rich fibrin is known for its content of growth factors and effects on soft tissue healing. Aim: The study aim is to compare the surgical management of gingival recession with tunnel technique using connective tissue graft and injectable platelet rich fibrin to tunnel with connective graft without injectable platelet rich fibrin.
Methodology: 30 patients with miller class I or II gingival recession will be enrolled. 15 in the test group (Tunnel+ CTG+ i-PRF) and 15 in control group (Tunnel+ CTG). Clinical evaluation at 6 months
Detailed description
30 patients with miller class I/II gingival recession will be enrolled in this study.
15 patients will be treated using tunnel technique and palatal connective tissue graft inserted and sutured under the prepared tunnel after being soaked in injectable platelet rich fibrin for 15 minutes. The tunnel with the underlying graft will be advanced coronally. (Test Group) The other 15 patients will be treated the same way as in the first group but without soaking the graft in injectable platelet rich fibrin. (Control Group) Clinical parameters will be evaluated at baseline and 6 months follow-up except post-operative pain which will be assessed after 10 days. Histologic examination of small piece of the graft will be done to assess if there is true saturation of growth factors inside the graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group: tunnel with connective tissue graft and injectable platelet rich fibrin | Experimental | Procedure: Tunnel with connective tissue graft and injectable platelet rich fibrinTunneling will be performed at the recession defect sites with insertion of palatal connective tissue graft taken from the patient hard palate inside the prepared tunnel. The graft will be soaked ,before insertion inside the tunnel, in injectable platelet rich fibrin ,prepared from patient own blood for 15 minutes. The tunnel with the soaked graft inside will be advanced coronally. |
| Control group: tunnel with connective tissue graft only | Active comparator | Procedure: Tunnel with connective tissue graft onlyTunnel preparation will be made in the recession defect sites with insertion of palatal connective tissue graft from the patient hard palate. The tunnel with the graft will be advanced coronally. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- More than 21 years old
- Systemically healthy
- Presence of Miller class I/II gingival recession
- Presence of identifiable CEJ
Key exclusion criteria (5 listed)
- Smoking
- Systemic disease that contraindicates surgical procedures.
- Poor compliance with oral hygiene measures
- Necrotizing gingival conditions
- Ongoing active periodontitis
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 |
|---|---|---|
| Tunnel with connective tissue graft and injectable platelet rich fibrinTunnel with connective tissue graft and injectable platelet rich fibrin | Procedure or surgery | Test group: tunnel with connective tissue graft and injectable platelet rich fibrin |
| Tunnel with connective tissue graft onlyTunnel technique with connective tossue graft only without injectable platelet rich fibrin | Procedure or surgery | Control group: tunnel with connective tissue graft only |
Primary outcome
Recession depth
Time frame: 6 months after the surgery
it will be recorded as the distance between the CEJ and gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.
Keratinized tissue height
Time frame: 6 months
It will be measured from the mucogingival junction to the gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.
Gingival thickness
Time frame: 6 months
It will be measured at a mid-buccal location 1 mm apical to the probing depth level with an spreader. It will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface. Penetration depth will be measured.
2 secondary outcomes
Post operative pain
Time frame: 10 days
Recession width
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 42359019Mahmoud MNA, Elrefaei AMH, Shata MS, Rokaya D, Morsy SM. Connective tissue graft with injectable platelet rich fibrin for treatment of RT1 gingival recession by tunnel technique: a randomized clinical and immunohistochemical study. Front Oral Health. 2026 Jun 10;7:1801423. doi: 10.3389/froh.2026.1801423. eCollection 2026.
- 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.
Abdelnasser Elrefaey study chair
Suez Canal University
Shaimaa Morsy study director
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tunnel with connective tissue graft and injectable platelet rich fibrin and Tunnel with connective tissue graft only in people with Gingival Recession, run by Suez Canal 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Abdel-aziz (00201118580817, mohamed_naser@dent.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession depth (time frame: 6 months after the surgery). The study lists 3 primary outcomes in all. 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 NCT06646432, 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 29 Jan 2025.