Gingival RecessionNCT06615687
Inverted T-shape Free Gingival Graft for Treatment of RT2 / RT3 Gingival Recession Defects
A study testing Inverted T shape Free Gingival Graft and Free Gingival Graft in people with Gingival Recession, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the use of T-inverted shape Free Gingival Graft with Free Gingival Graft for improving the clinical attachment, gain partial root coverage, and improve Keratinized tissue width in recession type 2 /recession type 3 gingival recession defects . Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Inverted T shape Free Gingival Graft and Free Gingival Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2024to Aug 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with RT2/RT3 gingival recession.
- Indication for FGG treatment at mandibular incisor area (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession.
- KT width (KTW) \< 2 mm.
- Ages 18-40 years old.
- Patients with healthy systemic condition (Brightman. 1994).
- Gingival and plaque index \<10.
- Good oral hygiene (Wiesner et al. 2010).
- Accepts 6 months follow-up period (cooperative patients)
Who cannot join
- Smokers.
- Poor oral hygiene.
- Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
- Intake of any medications known to affect gingival homeostasis or to interfere with wound healing.
- Pregnant or lactating women.
- RT1 gingival recession.
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- Caries or non-carious cervical lesions at recipient sites.
- Severely malpositioned teeth.
- Teeth with residual probing depth ≥ 4 mm.
- Mobility ≥ 1 mm.
- Pervious periodontal surgery within the last 6 months before the start of the trial.
- Patients with active periodontal disease. -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo university
Cairo
Dina Galal Hafeez, +201223996994, dina.hafeez@dentistry.cu.edu.eg
About this study
Official title: Inverted T-shape Free Gingival Graft Versus Free Gingival Graft for Treatment of RT2/RT3 Gingival Recession Defects : a Randomized Clinical Trial
The aim of this study is to compare the use of T-inverted shape Free Gingival Graft with Free Gingival Graft for improving the clinical attachment, gain partial root coverage, and improve Keratinized tissue width in recession type 2 /recession type 3 gingival recession defects .
Research question : In patients with RT2 / RT3 mandibular defects will the use of inverted T-shape free gingival graft differ from free gingival graft in Recession depth?
- Conditions
- Gingival Recession
- Being tested
- Inverted T shape Free Gingival Graft, Free Gingival Graft
- Keywords
- Inverted T-shape Free Gingival Graft, Gingival Recession, Free Gingival Graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inverted T shape Free Gingival GraftProcedure or surgery
the preparation of the recipient site commenced by making a horizontal incision at the mucogingival junction (MGJ) as well as two vertical incisions extending to the adjacent teeth and about 3-4 mm beyond the MGJ. A sharp split-thickness flap will be reflected, and the surfaces between these incisions will be de-epithelialized. Also, all the surfaces of the interdental papilla up to the lingual side will be de-epithelized using a 15c blade and microsurgical scissor .(Harvesting of the palatal donor site will be designed 2 mm away from the gingival margin using a template in the form of an inverted T-shape, taking into consideration the position of the greater palatine blood vessels at 5 mm. 2 mm is required for the width of the interproximal extension with 3 mm length to obtain an even thickness of 1-1.5 mm .
Placement of the graft : The Inverted T FGG will be inserted between the teeth to cover interproximal tissue defect and sutured lingually into the lingual marginal gingiva
Free Gingival GraftProcedure or surgery
Preparation of the recipient site :Following an intrasulcular incision, 2 mm-long horizontal incisions at the level of the CEJ will be performed bilaterally. From these, vertical releasing incisions will be placed in a diverging manner, extending well into the alveolar mucosa, a thin partial thickness flap will be subsequently raised then excised. The dimension of the resulting site will be measured to obtain a rectangular foil template .
Harvesting of the Graft :Using the foil template, graft dimensions will be outlined in the palate adjacent to the premolars and first molar. A partial thickness graft consisting of epithelium and a thin layer of underlying connective tissue will be harvested (intended total thickness of graft: 1.5 mm), maintaining a distance of ≥2 mm to the maxillary teeth.
| Study group | Role | What they receive |
|---|---|---|
| Inverted T -Shape Free Gingival Graft | Experimental | Not described Receives: Procedure: Inverted T shape Free Gingival Graft |
| Free Gingival Graft | Active comparator | Not described Receives: Procedure: Free Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession depth.
Will be measured as the distance from the CEJ to the most apical extension of the gingival margin.
Measured: baseline, 1 month , 3 months and 6 months
Secondary outcomes (8)
Width of keratinized gingiva .
Will be measured from the MGJ to the free gingival margin. The MGJ will be identified using the roll technique.
Measured: baseline, 1 month , 3 months and 6 months
Recession width
Will be measured as the distance from mesial and distal papillae along the CEJ
Measured: baseline, 1 month , 3 months and 6 months
Gingival thickness
An endodontic file and a 3 mm diameter silicon disc stop will be used to measure gingival thickness 2mm apical to the gingival border. The file will be inserted into the soft tissue with mild pressure, perpendicular to the mucosal surface, until a firm surface is felt. The silicon disc stop will be then pressed against the soft tissue, with the coronal border covering the soft tissue boundary.GT will be measured 2 mm apical from the gingival margin
Measured: baseline, 1 month , 3 months and 6 months
Root coverage esthetic score
The RES system evaluated five variables 6 months following surgery: GM, marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC). The clinical esthetic evaluation performed without magnification. Zero, 3, or 6 points were used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point was used for each of the other variables.
Measured: baseline, 1 month , 3 months and 6 months
The Distance between the contact point and the top of the papilla (DCP).
Measured as the distance between contact point and the tip of the papilla (DCP) in mms using UNC periodontal probe .
Measured: baseline, 1 month , 3 months and 6 months
Probing Depth
The assessment of probing depth will be measured from the gingival margin to the bottom of the sulcus using a periodontal probe, rounded to the nearest millimeter.
Measured: baseline, 1 month , 3 months and 6 months
Gingival Index
0 Normal gingiva.
- Mild inflammation.
- Moderate inflammation.
- Severe inflammation.
Measured: baseline, 1 month , 3 months and 6 months
Plaque Index
0 No plaque in the gingival area.
- 1 A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- 2 Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- 3 Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Measured: baseline, 1 month , 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionAug 2025 (estimated)
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.
- 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
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Galal Fouad Mohamed Hafeez, Cairo University
- Investigators
- Dina Galal Hafeez, Bachelor, Principal investigator, Cairo UniversityManar El-Zanaty, lecturer, Study chair, Cairo UniversityNoha Ghallab, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615687
- Sponsor's protocol ID
- Dgalal33724
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 26 Sep 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inverted T-shape Free Gingival Graft Versus Free Gingival Graft for Treatment of RT2/RT3 Gingival Recession Defects : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06615687
- Acronym / sponsor ID
- Dgalal33724
- Conditions
- Gingival Recession
- Keywords
- Inverted T-shape Free Gingival Graft, Gingival Recession, Free Gingival Graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 26 Sep 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 this study is to compare the use of T-inverted shape Free Gingival Graft with Free Gingival Graft for improving the clinical attachment, gain partial root coverage, and improve Keratinized tissue width in recession type 2 /recession type 3 gingival recession defects .
Research question : In patients with RT2 / RT3 mandibular defects will the use of inverted T-shape free gingival graft differ from free gingival graft in Recession depth?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inverted T -Shape Free Gingival Graft | Experimental | Procedure: Inverted T shape Free Gingival Graft |
| Free Gingival Graft | Active comparator | Procedure: Free Gingival Graft |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with RT2/RT3 gingival recession.
- Indication for FGG treatment at mandibular incisor area (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession.
- KT width (KTW) \< 2 mm.
- Ages 18-40 years old.
- Patients with healthy systemic condition (Brightman. 1994).
Key exclusion criteria (12 listed)
- Smokers.
- Poor oral hygiene.
- Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
- Intake of any medications known to affect gingival homeostasis or to interfere with wound healing.
- Pregnant or lactating women.
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 |
|---|---|---|
| Inverted T shape Free Gingival Graftthe preparation of the recipient site commenced by making a horizontal incision at the mucogingival junction (MGJ) as well as two vertical incisions extending to the adjacent teeth and about 3-4 mm beyond the MGJ. A sharp split-thickness flap will be reflected, and the surfaces between these incisions will be de-epithelialized. Also, all the surfaces of the interdental papilla up to the lingual side will be de-epithelized using a 15c blade and microsurgical scissor .(Harvesting of the palatal donor site will be designed 2 mm away from the gingival margin using a template in the form of an inverted T-shape, taking into consideration the position of the greater palatine blood vessels at 5 mm. 2 mm is required for the width of the interproximal extension with 3 mm length to obtain an even thickness of 1-1.5 mm . Placement of the graft : The Inverted T FGG will be inserted between the teeth to cover interproximal tissue defect and sutured lingually into the lingual marginal gingiva | Procedure or surgery | Inverted T -Shape Free Gingival Graft |
| Free Gingival GraftPreparation of the recipient site :Following an intrasulcular incision, 2 mm-long horizontal incisions at the level of the CEJ will be performed bilaterally. From these, vertical releasing incisions will be placed in a diverging manner, extending well into the alveolar mucosa, a thin partial thickness flap will be subsequently raised then excised. The dimension of the resulting site will be measured to obtain a rectangular foil template . Harvesting of the Graft :Using the foil template, graft dimensions will be outlined in the palate adjacent to the premolars and first molar. A partial thickness graft consisting of epithelium and a thin layer of underlying connective tissue will be harvested (intended total thickness of graft: 1.5 mm), maintaining a distance of ≥2 mm to the maxillary teeth. | Procedure or surgery | Free Gingival Graft |
Primary outcome
Recession depth.
Time frame: baseline, 1 month , 3 months and 6 months
Will be measured as the distance from the CEJ to the most apical extension of the gingival margin.
8 secondary outcomes
Width of keratinized gingiva .
Time frame: baseline, 1 month , 3 months and 6 months
Recession width
Time frame: baseline, 1 month , 3 months and 6 months
Gingival thickness
Time frame: baseline, 1 month , 3 months and 6 months
Root coverage esthetic score
Time frame: baseline, 1 month , 3 months and 6 months
The Distance between the contact point and the top of the papilla (DCP).
Time frame: baseline, 1 month , 3 months and 6 months
Probing Depth
Time frame: baseline, 1 month , 3 months and 6 months
Gingival Index
Time frame: baseline, 1 month , 3 months and 6 months
Plaque Index
Time frame: baseline, 1 month , 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 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.
Dina Galal Hafeez, Bachelor principal investigator
Cairo University
Manar El-Zanaty, lecturer study chair
Cairo University
Noha Ghallab, Professor study director
Cairo 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 Inverted T shape Free Gingival Graft and Free Gingival Graft in people with Gingival Recession, 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 8 inclusion and 12 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 26 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Galal Hafeez (+201223996994, dina.hafeez@dentistry.cu.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: baseline, 1 month , 3 months and 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 26 Sep 2024.