Gingival RecessionNCT05688293
Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries
A study testing Connective tissue graft, Free gingival graft and Non surgical in people with Gingival Recession, run by Misr International University at 1 site in Egypt.
Trial summary
Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Connective tissue graft, Free gingival graft and Non surgical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2025to 1 Mar 2027
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients (American Society of Anesthesiologists I; ASA I)
- Patients diagnosed with recession (RT1)
- Fair oral hygiene
- Patient accepting to provides an informed consent and the follow-up
Who cannot join
- Carious teeth and teeth with periapical infection.
- Patients diagnosed with periodontitis
- Smokers
- Pregnant and lactating females
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shahinaz Al ashiry, Asso. Prof contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of oral and dental medicine, Misr international university
Cairo, 12345
Zainab Hafez, Lecturer, zeinab.hafez@miuegypt.edu.eg
Yahia amer, Lecturer, yahia.hassan@miuegypt.edu.eg
About this study
Official title: Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study
Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.
Read the detailed description
This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
- Conditions
- Gingival Recession
- Being tested
- Connective tissue graft, Free gingival graft, Non surgical
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graftProcedure or surgery
non-surgical periodontal treatment and connective tissue graft
Free gingival graftProcedure or surgery
will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft
Non surgicalProcedure or surgery
non-surgical periodontal treatment only
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue graft | Active comparator | Patients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique Receives: Procedure: Connective tissue graft |
| Free gingival Graft | Active comparator | Patients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft Receives: Procedure: Free gingival graft |
| Non surgical procedure | Active comparator | Patients will receive non-surgical periodontal treatment only Receives: Procedure: Non surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival phenotype change
determination of the change in gingival thickness in mm using periodontal probe
Measured: at baseline 3,6 and 12 months
Secondary outcomes (2)
Keratinized tissue width
determination of Keratinized tissue width in mm using periodontal probe
Measured: at baseline 3,6 and 12 months
Root coverage esthetic score (RES)
It is a scoring system to assess the level of gingival margin (GM),marginal tissue contour (MTC),Soft tissue texture, Mucogingival alignment (MGJ),Gingival color The score is 0,1 and 3 where 0 is the minimum and 3 is the maximum
Measured: at baseline 3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start5 Feb 2025
- Primary completion20 Jan 2027 (estimated)
- Study completion1 Mar 2027 (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.
- 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
- Model description
- Three parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zainab Hafez, Lecturer, Principal investigator, Lecturer, faculty of oral and dental medicine misr international universityShahinaz Al ashiry, Asso. Prof, Study director, Associate professor, faculty of oral and dental medicine misr international universityYahia Amer, Lecturer, Principal investigator, Lecturer, faculty of oral and dental medicine misr international universit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688293
- Sponsor's protocol ID
- PER 5213005
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05688293
- Acronym / sponsor ID
- PER 5213005
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 18 Jan 2023 (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.
Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.
Detailed description
This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three parallel groups
| Arm | Type | Receives |
|---|---|---|
| Connective tissue graft | Active comparator | Procedure: Connective tissue graftPatients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique |
| Free gingival Graft | Active comparator | Procedure: Free gingival graftPatients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft |
| Non surgical procedure | Active comparator | Procedure: Non surgicalPatients will receive non-surgical periodontal treatment only |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Medically free patients (American Society of Anesthesiologists I; ASA I)
- Patients diagnosed with recession (RT1)
- Fair oral hygiene
- Patient accepting to provides an informed consent and the follow-up
Key exclusion criteria (4 listed)
- Carious teeth and teeth with periapical infection.
- Patients diagnosed with periodontitis
- Smokers
- Pregnant and lactating females
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 |
|---|---|---|
| Connective tissue graftnon-surgical periodontal treatment and connective tissue graft | Procedure or surgery | Connective tissue graft |
| Free gingival graftwill receive non-surgical periodontal treatment and partially de-epithelized free gingival graft | Procedure or surgery | Free gingival Graft |
| Non surgicalnon-surgical periodontal treatment only | Procedure or surgery | Non surgical procedure |
Primary outcome
Gingival phenotype change
Time frame: at baseline 3,6 and 12 months
determination of the change in gingival thickness in mm using periodontal probe
2 secondary outcomes
Keratinized tissue width
Time frame: at baseline 3,6 and 12 months
Root coverage esthetic score (RES)
Time frame: at baseline 3,6 and 12 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 6 Jul 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.
Shahinaz Al ashiry, Asso. Prof contact
Zainab Hafez, Lecturer principal investigator
Lecturer, faculty of oral and dental medicine misr international university
Shahinaz Al ashiry, Asso. Prof study director
Associate professor, faculty of oral and dental medicine misr international university
Yahia Amer, Lecturer principal investigator
Lecturer, faculty of oral and dental medicine misr international universit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue graft, Free gingival graft and Non surgical in people with Gingival Recession, run by Misr International 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 4 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 6 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?
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 Zainab Hafez, Lecturer (+01221334637, zeinab.hafez@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival phenotype change (time frame: at baseline 3,6 and 12 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 6 Jul 2026.