Gingival Recession, LocalizedNCT07162207
Bi-layer Collagen Membrane Versus Subepithelial Connective Tissue Graft in the Treatment of Localized Gingival Recession
A study testing Pinhole surgical technique in people with Gingival Recession, Localized, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is evaluation of the change in depth and width of gingival recession in terms of gingival thickness and esthetics, and evaluation of patient satisfaction in terms of postoperative pain and final esthetic appearance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- Pinhole surgical technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 30 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients have ages above 18 years.
- Patients included in the study are classified with Cairo RT1 and RT2 localized recession defect Cairo et al. (2011).
- Patients have at least 1 mm of residual keratinized tissue.
- Recession depth ≥ 2mm.
- Recession is not caused by periodontal disease.
- Patients have good oral hygiene.
Who cannot join
- Patients with systemic diseases.
- Pregnant and lactating women.
- Smoking patients and drug abusers.
- Patients with mal-positioned and rotated teeth.
- Patients with periodontally affected teeth adjacent to the treated sites.
- Patients having carious lesions or restorations in the treated teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Pinhole Surgical Technique Using Bi-layer Collagen Membrane Versus Subepithelial Connective Tissue Graft in the Treatment of Localized Gingival Recession: A Randomized Clinical Trial
The goal of this clinical trial is evaluation of the change in depth and width of gingival recession in terms of gingival thickness and esthetics, and evaluation of patient satisfaction in terms of postoperative pain and final esthetic appearance.
The study will be conducted on twelve Egyptian healthy patients with localized gingival recession. Researchers will compare clinical effectiveness of collagen membrane to connective tissue graft in treatment of localized gingival recession. The study hypothesis is that no difference exists between Bilayer collagen membrane combined with Pinhole approach and CT graft combined with Pinhole approach used for root coverage in treatment of localized gingival recession.
Read the detailed description
Twenty patients with localized gingival recession were randomly assigned into two equal groups. The control group received treatment with modified Pinhole surgical approach using connective tissue graft material, while the comparison group received treatment with Pinhole surgical approach using collagen membrane. Patients were followed up after 3 and 6 months from treatment.
- Conditions
- Gingival Recession, Localized
- Being tested
- Pinhole surgical technique
- Keywords
- Gingival recession, pinhole surgical technique, Connective tissue graft, Bi-layer collagen membrane
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pinhole surgical techniqueProcedure or surgery
A pinhole is created in the site of recession, the grafting material (Bi-layer collagen membrane versus connective tissue graft) is trimmed to fit the size of the recession defect, followed by graft insertion in the tunnel.
| Study group | Role | What they receive |
|---|---|---|
| Sub Epithelial Connective tissue graft | Active comparator | A pinhole is created in the site of recession. After harvesting the connective tissue graft from the palate it's trimmed and inserted in the tunnel. Receives: Procedure: Pinhole surgical technique |
| Bi-layer collagen membrane | Experimental | A pinhole is created in the site of recession, the Bi-layer collagen membrane is trimmed to fit the size of the recession defect, followed by membrane insertion in the tunnel. Receives: Procedure: Pinhole surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in depth of gingival recession (RD)
-This clinical parameter will be measured to evaluate the primary outcome: (unit of measurement: millimeters).
- This parameter will be recorded at baseline (just prior to the surgery) as well as at the 3rd month and 6th month follow up for Group 1 and Group 2.
Measured: The change from enrollment to 24 weeks.
The change in the width of gingival recession.
This clinical parameter will be measured to evaluate the primary outcome: (unit of measurement: millimeters).
- This parameter will be recorded at baseline (just prior to the surgery) as well s at the 3rd month and 6th month follow up for Group 1 and Group 2.
Measured: The change from enrollment to 24 weeks.
Plaque index (PI):
- Plaque index is based on recording both soft debris and mineralized deposits for each surface of the teeth (buccal, lingual, mesial and distal). Each of the four surfaces of the teeth is given a score from 0-3.
Measured: This parameter is measured at baseline, 3 and 6 months postoperatively.
Gingival index (GI)
- Gingival index is measured by giving a score from 0-3 for each surface of the four surfaces of the tooth then divided by four to give gingival index of each tooth.
Measured: This parameter is measured at baseline, 3 and 6 months postoperatively.
Probing depth (PD)
- Probing depth is measured from the gingival margin to the depth of the gingival sulcus using UNC-15 periodontal probe at 6 sites for each tooth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual surface.
Measured: This parameter will be recorded at baseline, 3 and 6 months postoperatively.
Clinical attachment level (CAL)
- Clinical attachment level is measured from the cemento-enamel junction (CEJ) to the depth of the gingival sulcus.
Measured: CAL will be measured at baseline, 3 and 6 months postoperatively.
Percentage of mean root coverage (MRC %)
Percentage of mean root coverage is calculated as: ([RD preoperative - RD postoperative]/ RD preoperative) × 100 % (unit of measurement: Percentage % ).
Measured: MRC% is recorded at baseline, 3 and 6 months postoperatively.
Width of keratinized tissue (KTW)
Width of keratinized tissue (KTW) is measured from the most apical extension of gingival margin to the mucogingival line.
Measured: This parameter is measured at baseline, 3 and 6 months postoperatively.
Gingival thickness (GT)
Gingival thickness (GT) is measured using UNC-15 periodontal probe with piercing the mucosal surface at a right angle with slight pressure until reaching the hard tissue. The distance between the tip of the probe and the outer mark is measured.
Measured: This parameter is recorded at baseline, 3 and 6 months postoperative.
Secondary outcomes (2)
Evaluation of patient satisfaction in terms of post-operative pain.
It's assessed by using verbal, numeric scale and by recording amount of analgesic intake postoperatively. The numerical rating Scale (NRS) pain score: is a psychometric response to pain reported by the patient directly through a score (between 0 and 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain). This was done through a questionnaire two weeks after surgery.
Measured: assessment at two weeks postoperative time.
Evaluation of patient satisfaction in terms of final esthetic appearance.
The clinical parameter: Root coverage esthetic score (RES) will be measured to evaluate the secondary outcome, time of evaluation at 6 months follow up time.
- It is used to evaluate five variables and recorded at 6 months following surgery; these variables are gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MCJ alignment and gingival color (GC). Then; giving score for each variable and added them to give score as the following GM: zero points= failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points= partial root coverage; 5 points= Complete root coverage (CRC). MTC, STT, MGJ, GC are given zero point and 1 point according to certain criteria.
Measured: The change from enrollment to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Feb 2024
- Primary completion1 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Elleithy, Ain Shams University
- Investigators
- Hala A. Abu El-Ela, Professor, Study director, Faculty of Dentistry- Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162207
- Sponsor's protocol ID
- FDASU-REC 052317
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2025
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Pinhole Surgical Technique Using Bi-layer Collagen Membrane Versus Subepithelial Connective Tissue Graft in the Treatment of Localized Gingival Recession: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07162207
- Acronym / sponsor ID
- FDASU-REC 052317
- Conditions
- Gingival Recession, Localized
- Keywords
- Gingival recession, pinhole surgical technique, Connective tissue graft, Bi-layer collagen membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 9 Sep 2025 (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 goal of this clinical trial is evaluation of the change in depth and width of gingival recession in terms of gingival thickness and esthetics, and evaluation of patient satisfaction in terms of postoperative pain and final esthetic appearance.
The study will be conducted on twelve Egyptian healthy patients with localized gingival recession. Researchers will compare clinical effectiveness of collagen membrane to connective tissue graft in treatment of localized gingival recession. The study hypothesis is that no difference exists between Bilayer collagen membrane combined with Pinhole approach and CT graft combined with Pinhole approach used for root coverage in treatment of localized gingival recession.
Detailed description
Twenty patients with localized gingival recession were randomly assigned into two equal groups. The control group received treatment with modified Pinhole surgical approach using connective tissue graft material, while the comparison group received treatment with Pinhole surgical approach using collagen membrane. Patients were followed up after 3 and 6 months from treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub Epithelial Connective tissue graft | Active comparator | Procedure: Pinhole surgical techniqueA pinhole is created in the site of recession. After harvesting the connective tissue graft from the palate it's trimmed and inserted in the tunnel. |
| Bi-layer collagen membrane | Experimental | Procedure: Pinhole surgical techniqueA pinhole is created in the site of recession, the Bi-layer collagen membrane is trimmed to fit the size of the recession defect, followed by membrane insertion in the tunnel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients have ages above 18 years.
- Patients included in the study are classified with Cairo RT1 and RT2 localized recession defect Cairo et al. (2011).
- Patients have at least 1 mm of residual keratinized tissue.
- Recession depth ≥ 2mm.
- Recession is not caused by periodontal disease.
Key exclusion criteria (6 listed)
- Patients with systemic diseases.
- Pregnant and lactating women.
- Smoking patients and drug abusers.
- Patients with mal-positioned and rotated teeth.
- Patients with periodontally affected teeth adjacent to the treated sites.
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 |
|---|---|---|
| Pinhole surgical techniqueA pinhole is created in the site of recession, the grafting material (Bi-layer collagen membrane versus connective tissue graft) is trimmed to fit the size of the recession defect, followed by graft insertion in the tunnel. | Procedure or surgery | Bi-layer collagen membrane, Sub Epithelial Connective tissue graft |
Primary outcome
The change in depth of gingival recession (RD)
Time frame: The change from enrollment to 24 weeks.
-This clinical parameter will be measured to evaluate the primary outcome: (unit of measurement: millimeters). - This parameter will be recorded at baseline (just prior to the surgery) as well as at the 3rd month and 6th month follow up for Group 1 and Group 2.
The change in the width of gingival recession.
Time frame: The change from enrollment to 24 weeks.
This clinical parameter will be measured to evaluate the primary outcome: (unit of measurement: millimeters). - This parameter will be recorded at baseline (just prior to the surgery) as well s at the 3rd month and 6th month follow up for Group 1 and Group 2.
Plaque index (PI):
Time frame: This parameter is measured at baseline, 3 and 6 months postoperatively.
- Plaque index is based on recording both soft debris and mineralized deposits for each surface of the teeth (buccal, lingual, mesial and distal). Each of the four surfaces of the teeth is given a score from 0-3.
Gingival index (GI)
Time frame: This parameter is measured at baseline, 3 and 6 months postoperatively.
- Gingival index is measured by giving a score from 0-3 for each surface of the four surfaces of the tooth then divided by four to give gingival index of each tooth.
Probing depth (PD)
Time frame: This parameter will be recorded at baseline, 3 and 6 months postoperatively.
- Probing depth is measured from the gingival margin to the depth of the gingival sulcus using UNC-15 periodontal probe at 6 sites for each tooth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual surface.
Clinical attachment level (CAL)
Time frame: CAL will be measured at baseline, 3 and 6 months postoperatively.
- Clinical attachment level is measured from the cemento-enamel junction (CEJ) to the depth of the gingival sulcus.
Percentage of mean root coverage (MRC %)
Time frame: MRC% is recorded at baseline, 3 and 6 months postoperatively.
Percentage of mean root coverage is calculated as: ([RD preoperative - RD postoperative]/ RD preoperative) × 100 % (unit of measurement: Percentage % ).
Width of keratinized tissue (KTW)
Time frame: This parameter is measured at baseline, 3 and 6 months postoperatively.
Width of keratinized tissue (KTW) is measured from the most apical extension of gingival margin to the mucogingival line.
Gingival thickness (GT)
Time frame: This parameter is recorded at baseline, 3 and 6 months postoperative.
Gingival thickness (GT) is measured using UNC-15 periodontal probe with piercing the mucosal surface at a right angle with slight pressure until reaching the hard tissue. The distance between the tip of the probe and the outer mark is measured.
2 secondary outcomes
Evaluation of patient satisfaction in terms of post-operative pain.
Time frame: assessment at two weeks postoperative time.
Evaluation of patient satisfaction in terms of final esthetic appearance.
Time frame: The change from enrollment to 24 weeks
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 2 Nov 2026.
- Pubmed in a database that has been used globally for research purposesLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Hala A. Abu El-Ela, Professor study director
Faculty of Dentistry- Ain Shams 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 Pinhole surgical technique in people with Gingival Recession, Localized, run by Ain Shams 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 6 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 2 Nov 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?
The change in depth of gingival recession (RD) (time frame: The change from enrollment to 24 weeks.). The study lists 9 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 2 Nov 2026.