Gingival RecessionNCT04513041
Pinhole Versus Tunnel for Soft Tissue Recession
A study testing Pinhole surgical technique and tunnel technique in a split mouth design in people with Gingival Recession, run by Mohanad Al-Sabbagh at 1 site in United States.
Trial summary
This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Pinhole surgical technique and tunnel technique in a split mouth design
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 6 Aug 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18-75 years old
- have at least one non-mobile tooth with Cairo class I gingival recession of 2 to 6 mm.
- American Society of Anesthesiology class I and II
- full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) below 20%
Who cannot join
- sites of gingival recession around teeth that are non-salvageable
- presence of any exudate, infection or local inflammation around the area to be grafted
- pregnant or breastfeeding females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pinhole Surgical Technique and Tunnel Technique for the Treatment of Gingival Recession: A Split Mouth Clinical and Digital Study
This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique.
Read the detailed description
Each patient will undergo both surgeries on either quadrant; the PST and tunnel technique. The site will be randomized to receive either type of surgeries. Both types of surgeries are considered minimally invasive procedures to obtain root coverage for gingival recession. Both surgeries are clinically utilized in clinical practice and yield comparable results according to the literature, however, No prospective studies are published to compare between the outcomes of both techniques. patients will receive intra oral scan before the surgery and 6 months after the surgery to compare change in root coverage and gingival thickness outcomes between the two techniques. Post operative pain as well as patient satisfaction will be measured by visual analog scale and compared between the two techniques. Patients will be monitored at different time points to asses healing.
- Conditions
- Gingival Recession
- Being tested
- Pinhole surgical technique and tunnel technique in a split mouth design
- 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 technique and tunnel technique in a split mouth designProcedure or surgery
Each subject will have the each surgical procedure which are both considered routine minimally invasive clinical care for gingival recession. Gum recession on one side will receive Pinhole surgical technique (test procedure). The other side will receive Tunnel technique (control procedure), Research component involved is the capture of digital impression using intra-oral scanner in the baseline (preoperative) and the final visit (6 months postoperative).
| Study group | Role | What they receive |
|---|---|---|
| Pinhole/Tunnel | Experimental | Participants will receive Pinhole surgical technique for treatment of soft tissue recession at one side of the mouth and Tunnel technique for treatment of soft tissue recession at the other side of the mouth Receives: Procedure: Pinhole surgical technique and tunnel technique in a split mouth design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival thickness
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival thickness.
Measured: 6 months (pre operative and at the 6-month follow-up visit)
Change in gingival recession
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival recession.
Measured: 6 months (pre operative and at the 6-month follow-up visit)
Secondary outcomes (8)
Change in papillary recession
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure papillary gingival recession.
Measured: 6 months (pre operative and at the 6-month follow-up visit)
Change in root coverage
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the complete elimination of gingival recession.
Measured: 6 months (pre operative and at the 6-month follow-up visit)
Change in sulcus probing depth
During a clinical exam, a sulcus will be used to measure the depth from the free gingival margin to the base of the sulcus pre- and 6-months post-operative.
Measured: 6 months (pre operative and at the 6-month follow-up visit)
Change in clinical attachment.
Clinical attachment will be calculated during the pre- and post-operative clinical exam.
Measured: 6 months (pre operative and at the 6-month follow-up visit)
Change in zone of keratinized tissue
During a clinical exam, the zone of keratinized tissue will be measured during the pre- and post-operative clinical exam.
Measured: 6 months (pre operative and at the 6-month follow-up visit)
Change in bleeding on probing.
The presence or absense of bleeding during probing during will be noted during the pre- and post-operative clinical exam.
Measured: 6 months (pre operative and at the 6-month follow-up visit)
Post-operative pain
A Visual Analog Score for pain will be used to assess post-operative pain one week after surgery. Scores range from 0-10; higher scores indicate greater pain.
Measured: 1 week
Aesthetic satisfaction
A Visual Analog Score for aesthetic satisfaction will be used to assess patient satisfaction 6 months after surgery. Scores range from 0-10; higher scores indicate greater satisfaction.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start25 Jun 2020
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
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
- Not applicable
- Intervention model
- Single group
- Model description
- Right and left sides of the mouth will be randomly assigned to test and control group by computer generated randomization table in a split mouth design
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohanad Al-Sabbagh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohanad Al-Sabbagh, University of Kentucky
- Investigators
- Mohanad Al-Sabbagh, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513041
- Sponsor's protocol ID
- 80275
- Status last verified
- Feb 2026
- First submitted
- 29 Jul 2020
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participants data will not be shared, rather the accumulated data for all participants could be shared to eliminate identification of participants.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pinhole Surgical Technique and Tunnel Technique for the Treatment of Gingival Recession: A Split Mouth Clinical and Digital Study
- ClinicalTrials.gov ID
- NCT04513041
- Acronym / sponsor ID
- 80275
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mohanad Al-SabbaghUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 14 Aug 2020 (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.
This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique.
Detailed description
Each patient will undergo both surgeries on either quadrant; the PST and tunnel technique. The site will be randomized to receive either type of surgeries. Both types of surgeries are considered minimally invasive procedures to obtain root coverage for gingival recession. Both surgeries are clinically utilized in clinical practice and yield comparable results according to the literature, however, No prospective studies are published to compare between the outcomes of both techniques. patients will receive intra oral scan before the surgery and 6 months after the surgery to compare change in root coverage and gingival thickness outcomes between the two techniques. Post operative pain as well as patient satisfaction will be measured by visual analog scale and compared between the two techniques. Patients will be monitored at different time points to asses healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Right and left sides of the mouth will be randomly assigned to test and control group by computer generated randomization table in a split mouth design
| Arm | Type | Receives |
|---|---|---|
| Pinhole/Tunnel | Experimental | Procedure: Pinhole surgical technique and tunnel technique in a split mouth designParticipants will receive Pinhole surgical technique for treatment of soft tissue recession at one side of the mouth and Tunnel technique for treatment of soft tissue recession at the other side of the mouth |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- between 18-75 years old
- have at least one non-mobile tooth with Cairo class I gingival recession of 2 to 6 mm.
- American Society of Anesthesiology class I and II
- full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) below 20%
Key exclusion criteria (3 listed)
- sites of gingival recession around teeth that are non-salvageable
- presence of any exudate, infection or local inflammation around the area to be grafted
- pregnant or breastfeeding 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 |
|---|---|---|
| Pinhole surgical technique and tunnel technique in a split mouth designEach subject will have the each surgical procedure which are both considered routine minimally invasive clinical care for gingival recession. Gum recession on one side will receive Pinhole surgical technique (test procedure). The other side will receive Tunnel technique (control procedure), Research component involved is the capture of digital impression using intra-oral scanner in the baseline (preoperative) and the final visit (6 months postoperative). | Procedure or surgery | Pinhole/Tunnel |
Primary outcome
Change in gingival thickness
Time frame: 6 months (pre operative and at the 6-month follow-up visit)
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival thickness.
Change in gingival recession
Time frame: 6 months (pre operative and at the 6-month follow-up visit)
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival recession.
8 secondary outcomes
Change in papillary recession
Time frame: 6 months (pre operative and at the 6-month follow-up visit)
Change in root coverage
Time frame: 6 months (pre operative and at the 6-month follow-up visit)
Change in sulcus probing depth
Time frame: 6 months (pre operative and at the 6-month follow-up visit)
Change in clinical attachment.
Time frame: 6 months (pre operative and at the 6-month follow-up visit)
Change in zone of keratinized tissue
Time frame: 6 months (pre operative and at the 6-month follow-up visit)
Change in bleeding on probing.
Time frame: 6 months (pre operative and at the 6-month follow-up visit)
Post-operative pain
Time frame: 1 week
Aesthetic satisfaction
Time frame: 1 day
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 17 Feb 2026.
- Individual participant dataSharing planned: No. Individual participants data will not be shared, rather the accumulated data for all participants could be shared to eliminate identification of participants.
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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.
Mohanad Al-Sabbagh principal investigator
University of Kentucky
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 and tunnel technique in a split mouth design in people with Gingival Recession, run by Mohanad Al-Sabbagh at 1 site in United States.
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 3 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 17 Feb 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 United States. 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 thickness (time frame: 6 months (pre operative and at the 6-month follow-up visit)). 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 17 Feb 2026.