Gingival RecessionNCT07467096
Vestibular Incision Subperiosteal Tunnel Access With Fascia Lata Allograft in The Treatment of Gingival Recession
A study testing Vestibular incision sub-periosteal tunnel access + fascia lata and Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graft in people with Gingival Recession, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The present study will be conducted as a randomized controlled clinical study to assess to evaluate the effect of minimally invasive VISTA with fascia lata allograft in the treatment of gingival recession Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Vestibular incision sub-periosteal tunnel access + fascia lata and Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Sep 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of gingival recession type 1 (RT1) Cairo classification (6)
- Gingival recession depth ≥ 2 mm.
- Gingival thickness for the site selected should be ≥1mm.
- The height of keratinized gingiva (HKG) for the site selected should be ≥2 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction).
- Optimal compliance as evidenced by no missed treatment appointments and a positive attitude toward oral hygiene.
Who cannot join
- Presence of any systemic disease that could influence the outcome of the therapy.
- Presence of any risk factor e.g.; smoker, pregnant and lactating patients.
- Previous history of periodontal surgical treatment in quadrant selected for the study.
- Restorations or caries in the area to be treated and non-vital tooth.
- Teeth which are tilted or rotated.
- Patients taking medications known to cause gingival enlargement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation The Efficacy of Vestibular Incision Subperiosteal Tunnel Access With Fascia Lata Allograft in The Treatment of Gingival Recession A Randomized Controlled Clinical Trial
The present study will be conducted as a randomized controlled clinical study to assess to evaluate the effect of minimally invasive VISTA with fascia lata allograft in the treatment of gingival recession
- Conditions
- Gingival Recession
- Being tested
- Vestibular incision sub-periosteal tunnel access + fascia lata, Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue 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.
Vestibular incision sub-periosteal tunnel access + fascia lataOther
The vestibular incision sub-periosteal tunnel access (VISTA) technique for all groups will be done and the patients will receive VISTA techniques with fascia lata
Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graftOther
The vestibular incision sub-periosteal tunnel access (VISTA) technique for all groups will be done and the patients will receive VISTA techniques with subepithelial connective tissue graft CTG
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Other: Vestibular incision sub-periosteal tunnel access + fascia lata |
| Control Group | Active comparator | Not described Receives: Other: Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Gingival recession depth
will be measured at the mid-buccal aspect of the tooth from the (CEJ) to the most apical point of the gingival margin (GM).
Measured: 2 weeks, 3 months, 6 months
change in Gingival recession width (GRW)
it will be measured at the mesiodistal direction of the GM at the level of CEJ
Measured: 2 weeks, 3 months, 6 months
Secondary outcomes (6)
change in Keratinized tissue width (KTW)
will be measured as the distance between the GM and the mucogingival junction (MGJ)
Measured: 2 weeks, 3 months, 6 months
change in Clinical attachment loss (CAL)
will be measured at the mid-buccal aspect of the tooth from CEJ to the bottom of the sulcus.
Measured: 2 weeks, 3 months, 6 months
change in Probing depth (PD)
it will be measured from the GM to the bottom of the sulcus.
Measured: 2 weeks, 3 months, 6 months
change in Gingival thickness (GT)
it will be measured at the mid-buccal aspect of a treated tooth on the long axis, 3 mm apically from the GM using K-file 25 ISO with a silicon marker driven perpendicularly to the gingival surface after application of local anesthesia.
Measured: 2 weeks, 3 months, 6 months
change in Recession esthetic score (RES)
it evaluates five outcome variables (GM level, marginal tissue contour, soft tissue texture, MGJ alignment, and gingival color) leading to a final score ranging from 0 to 10 points.
Measured: 2 weeks, 3 months, 6 months
change in Percentage of root coverage (RC)
it will be calculated at 3 and 6 months post- operative by the following formula: (GRD baseline - GRD 3/6 months)/GRD baseline × 100%
Measured: 2 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Mar 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467096
- Sponsor's protocol ID
- KFSIRB200-93
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 12 Mar 2026
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation The Efficacy of Vestibular Incision Subperiosteal Tunnel Access With Fascia Lata Allograft in The Treatment of Gingival Recession A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07467096
- Acronym / sponsor ID
- KFSIRB200-93
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 12 Mar 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.
The present study will be conducted as a randomized controlled clinical study to assess to evaluate the effect of minimally invasive VISTA with fascia lata allograft in the treatment of gingival recession
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: Vestibular incision sub-periosteal tunnel access + fascia lata |
| Control Group | Active comparator | Other: Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graft |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Presence of gingival recession type 1 (RT1) Cairo classification (6)
- Gingival recession depth ≥ 2 mm.
- Gingival thickness for the site selected should be ≥1mm.
- The height of keratinized gingiva (HKG) for the site selected should be ≥2 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction).
- Optimal compliance as evidenced by no missed treatment appointments and a positive attitude toward oral hygiene.
Key exclusion criteria (6 listed)
- Presence of any systemic disease that could influence the outcome of the therapy.
- Presence of any risk factor e.g.; smoker, pregnant and lactating patients.
- Previous history of periodontal surgical treatment in quadrant selected for the study.
- Restorations or caries in the area to be treated and non-vital tooth.
- Teeth which are tilted or rotated.
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 |
|---|---|---|
| Vestibular incision sub-periosteal tunnel access + fascia lataThe vestibular incision sub-periosteal tunnel access (VISTA) technique for all groups will be done and the patients will receive VISTA techniques with fascia lata | Other | Test Group |
| Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graftThe vestibular incision sub-periosteal tunnel access (VISTA) technique for all groups will be done and the patients will receive VISTA techniques with subepithelial connective tissue graft CTG | Other | Control Group |
Primary outcome
change in Gingival recession depth
Time frame: 2 weeks, 3 months, 6 months
will be measured at the mid-buccal aspect of the tooth from the (CEJ) to the most apical point of the gingival margin (GM).
change in Gingival recession width (GRW)
Time frame: 2 weeks, 3 months, 6 months
it will be measured at the mesiodistal direction of the GM at the level of CEJ
6 secondary outcomes
change in Keratinized tissue width (KTW)
Time frame: 2 weeks, 3 months, 6 months
change in Clinical attachment loss (CAL)
Time frame: 2 weeks, 3 months, 6 months
change in Probing depth (PD)
Time frame: 2 weeks, 3 months, 6 months
change in Gingival thickness (GT)
Time frame: 2 weeks, 3 months, 6 months
change in Recession esthetic score (RES)
Time frame: 2 weeks, 3 months, 6 months
change in Percentage of root coverage (RC)
Time frame: 2 weeks, 3 months, 6 months
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 12 Mar 2026.
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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 Vestibular incision sub-periosteal tunnel access + fascia lata and Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graft in people with Gingival Recession, run by Hams Hamed Abdelrahman 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 6 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 12 Mar 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?
change in Gingival recession depth (time frame: 2 weeks, 3 months, 6 months). The study lists 2 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 12 Mar 2026.