Gingival RecessionNCT06453369
A Novel Vertical Y-shaped Tunnel Approach Versus Modified Coronally Advanced Tunnel Technique, for The Treatment of Miller Class I Gingival Recession
A study testing Y shaped Tunnel with Connective tissue graft in people with Gingival Recession, run by October 6 University at 1 site in Egypt.
Trial summary
Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Y shaped Tunnel with Connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2022to 4 Feb 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age above 18 years old.
- The presence of Miller's class I gingival recession (25).
- Recession defect on maxillary incisors, maxillary and mandibular canines, or premolars.
- Absence of a history of periodontal surgery at the involved sites in the last 12 months.
- History of compliance with oral hygiene instructions and periodontal recall.
- Sufficient palatal donor tissue thickness (> 2mm).
- Clearly identifiable cemento-enamel-junction (CEJ)
Who cannot join
- Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc (26).
- Pregnant and lactating women
- Current use of any form of tobacco.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Vertical Y-shaped Tunnel Approach Versus Modified Coronally Advanced Tunnel Technique, for The Treatment of Miller Class I Gingival Recession - Randomized Clinical Trial
Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. In this study we propose a novel vertical tunnel technique as a minimally invasive approach (Vertical Y-shaped Tunnel Approach) and evaluate clinical results in comparison to CAMT, both using CTG. The novel technique allows stability of the graft, maximum coronal vascularity and minimum soft tissue reflection.
Read the detailed description
The tunnel technique is an approach that optimizes esthetics and predictability because of its ability to avoid releasing critical papillae and maintaining a high level of vascularity at the surgical site to support the grafts. The tunnel technique has a minimally invasive nature since the interdental papillae are left intact and vertical incisions are not performed which results in better esthetics. This technique entailed the placement of a connective tissue graft in the tunnel. Complete graft coverage is not mandatory as long as the graft dimensions are sufficient to ensure its survival. Avoiding detachment of the highly fragile interdental soft tissue can minimize the risk of losing papilla height in critical esthetic areas, avoid scar formation, maximize the papillary and lateral blood supply to the underlying graft and better stabilize the graft for optimal wound healing Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. In this study we propose a novel vertical tunnel technique as a minimally invasive approach (Vertical Y-shaped Tunnel Approach) and evaluate clinical results in comparison to CAMT, both using CTG. The novel technique allows stability of the graft, maximum coronal vascularity and minimum soft tissue reflection.
- Conditions
- Gingival Recession
- Being tested
- Y shaped Tunnel with Connective tissue graft
- Keywords
- gingival recession, Modified tunnel technique, tunnel technique, connective tissue graft, minimally invasive, root coverage
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y shaped Tunnel with Connective tissue graftProcedure or surgery
Sulcular incision followed by Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG insurted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures.
| Study group | Role | What they receive |
|---|---|---|
| root coverage using novel Y shaped Tunnel with Connective tissue graft | Experimental | Sulcular incision will be performed using 15c blade . Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. Micro periosteal elevator will be used to elevate the buccal aspect of both mesial and distal papillae of the affected tooth. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG will be inserted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures. Receives: Procedure: Y shaped Tunnel with Connective tissue graft |
| root coverage using MCAT with Connective tissue graft | Active comparator | The tunnel will be prepared with a full-thickness incision up to MGJ and as a split-thickness beyond MGJ using tunneling instruments to obtain a tension-free tunnel, allowing the insertion of the CTG, a delicate incision is performed at the level of interdental papillae and raised without detaching the tip of the papillae. The papillary regions will be detached in their buccal aspects. The adjacent papillae of the neighboring teeth will be involved in the preparation to ensure a coronal positioning of the flap. After planing, the graft will be inserted into the tunnel by a specific suture technique. The first suture will be inserted through the most distal recession part and the needle exits in the most medial part of the recession, second suture will be placed at the opposite side and the needle exits at the same medial recession. The buccal flap will be advanced coronally to cover CTG and secured with sling sutures. The donor CTG will stabilized to the underlying CT interproximally. Receives: Procedure: Y shaped Tunnel with Connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of root coverage
Percentage root coverage (%RC): calculated as ([RD preoperative - RD postoperative]/RD preoperative) × 100%.
Measured: 1 month, 3 and 6 months
Secondary outcomes (11)
Complete root coverage (CRC)
The number of sites that resulted in 100% root coverage.
Measured: 1 month, 3 and 6 months
Recession Depth (RD)
Measured in millimeters from the gingival margin at the midbuccal aspect of the root, to the CEJ or relative CEJ.
Measured: 1 month, 3 and 6 months
Recession width (RW)
The horizontal distance between the bilateral gingival margins at the height of the CEJ. (mm)
Measured: 1 month, 3 and 6 months
Probing depth (PD)
Measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth. (baseline and after 6 months)
Measured: 6 months
Clinical attachment level (CAL)
Measured in millimeters from CEJ or relative CEJ to the base of the periodontal sulcus at 6 sites per tooth. (after 6 months)
Measured: 6 months
Width of the keratinized tissue (KTW)
Measured in millimeters at midbuccal aspect of the tooth from the gingival margin to the mucogingival junction.
Measured: 1 month, 3 and 6 months
Gingival Thickness (GT)
Measured in millimeters at the mid-buccal of the gingiva and 2 mm apical the gingival margin at the attached gingiva or the alveolar mucosa using a #15 endodontic reamer with a silicon disk stop.
Measured: 6 months
Plaque index (PI)
Is used for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin.
Measured: 1 month, 3 and 6 months
Gingival index (GI)
GI is measured according to Loe and Sillness and scored on a scale of 0 to 3.
Measured: 1 month, 3 and 6 months
Pain index (PN)
Pain is recorded on a horizontal pain scale of 0-10, Pain index to be recorded by the patients at 9 am, 3pm, and 9 pm from the day of the surgery and for 3 weeks post-treatment.
Measured: 1 month, 3 and 6 months
Professional esthetic evaluation and patient-reported satisfaction
The esthetic outcome will be assessed post-operatively after 6 months by an independent second examiner (MS), who is blinded to the treatment assignment, in accordance with RES (30). The evaluation will be based on comparing digital photographs.
Five variables were assessed:
- the level of gingival margin (GM);
- marginal tissue contour (MTC);
- soft tissue texture (STT);
- muco-gingival junction alignment (MGJ); and
- gingival color (GC). A score of 0, 3, or 6 will be used for evaluation of GM, whereas a score of 0-1 will be used for each of the other variables. The ideal esthetic score will be 10.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start2 Mar 2022
- Primary completion4 Feb 2024
- Study completion4 Feb 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslam Ashraf Mogahed, October 6 University
- Investigators
- Aslam Ashraf Mogahed, BDs, Principal investigator, O6U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453369
- Sponsor's protocol ID
- 14-2022
- Status last verified
- Jun 2024
- First submitted
- 7 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Vertical Y-shaped Tunnel Approach Versus Modified Coronally Advanced Tunnel Technique, for The Treatment of Miller Class I Gingival Recession - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06453369
- Acronym / sponsor ID
- 14-2022
- Conditions
- Gingival Recession
- Keywords
- gingival recession, Modified tunnel technique, tunnel technique, connective tissue graft, minimally invasive, root coverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 4 Feb 2024 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 11 Jun 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.
Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. In this study we propose a novel vertical tunnel technique as a minimally invasive approach (Vertical Y-shaped Tunnel Approach) and evaluate clinical results in comparison to CAMT, both using CTG. The novel technique allows stability of the graft, maximum coronal vascularity and minimum soft tissue reflection.
Detailed description
The tunnel technique is an approach that optimizes esthetics and predictability because of its ability to avoid releasing critical papillae and maintaining a high level of vascularity at the surgical site to support the grafts. The tunnel technique has a minimally invasive nature since the interdental papillae are left intact and vertical incisions are not performed which results in better esthetics. This technique entailed the placement of a connective tissue graft in the tunnel. Complete graft coverage is not mandatory as long as the graft dimensions are sufficient to ensure its survival. Avoiding detachment of the highly fragile interdental soft tissue can minimize the risk of losing papilla height in critical esthetic areas, avoid scar formation, maximize the papillary and lateral blood supply to the underlying graft and better stabilize the graft for optimal wound healing Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. In this study we propose a novel vertical tunnel technique as a minimally invasive approach (Vertical Y-shaped Tunnel Approach) and evaluate clinical results in comparison to CAMT, both using CTG. The novel technique allows stability of the graft, maximum coronal vascularity and minimum soft tissue reflection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| root coverage using novel Y shaped Tunnel with Connective tissue graft | Experimental | Procedure: Y shaped Tunnel with Connective tissue graftSulcular incision will be performed using 15c blade . Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. Micro periosteal elevator will be used to elevate the buccal aspect of both mesial and distal papillae of the affected tooth. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG will be inserted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures. |
| root coverage using MCAT with Connective tissue graft | Active comparator | Procedure: Y shaped Tunnel with Connective tissue graftThe tunnel will be prepared with a full-thickness incision up to MGJ and as a split-thickness beyond MGJ using tunneling instruments to obtain a tension-free tunnel, allowing the insertion of the CTG, a delicate incision is performed at the level of interdental papillae and raised without detaching the tip of the papillae. The papillary regions will be detached in their buccal aspects. The adjacent papillae of the neighboring teeth will be involved in the preparation to ensure a coronal positioning of the flap. After planing, the graft will be inserted into the tunnel by a specific suture technique. The first suture will be inserted through the most distal recession part and the needle exits in the most medial part of the recession, second suture will be placed at the opposite side and the needle exits at the same medial recession. The buccal flap will be advanced coronally to cover CTG and secured with sling sutures. The donor CTG will stabilized to the underlying CT interproximally. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age above 18 years old.
- The presence of Miller's class I gingival recession (25).
- Recession defect on maxillary incisors, maxillary and mandibular canines, or premolars.
- Absence of a history of periodontal surgery at the involved sites in the last 12 months.
- History of compliance with oral hygiene instructions and periodontal recall.
Key exclusion criteria (3 listed)
- Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc (26).
- Pregnant and lactating women
- Current use of any form of tobacco.
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 |
|---|---|---|
| Y shaped Tunnel with Connective tissue graftSulcular incision followed by Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG insurted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures. | Procedure or surgery | root coverage using MCAT with Connective tissue graft, root coverage using novel Y shaped Tunnel with Connective tissue graft |
Primary outcome
percentage of root coverage
Time frame: 1 month, 3 and 6 months
Percentage root coverage (%RC): calculated as ([RD preoperative - RD postoperative]/RD preoperative) × 100%.
11 secondary outcomes
Complete root coverage (CRC)
Time frame: 1 month, 3 and 6 months
Recession Depth (RD)
Time frame: 1 month, 3 and 6 months
Recession width (RW)
Time frame: 1 month, 3 and 6 months
Probing depth (PD)
Time frame: 6 months
Clinical attachment level (CAL)
Time frame: 6 months
Width of the keratinized tissue (KTW)
Time frame: 1 month, 3 and 6 months
Gingival Thickness (GT)
Time frame: 6 months
Plaque index (PI)
Time frame: 1 month, 3 and 6 months
Gingival index (GI)
Time frame: 1 month, 3 and 6 months
Pain index (PN)
Time frame: 1 month, 3 and 6 months
Professional esthetic evaluation and patient-reported satisfaction
Time frame: 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 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Aslam Ashraf Mogahed, BDs principal investigator
O6U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y shaped Tunnel with Connective tissue graft in people with Gingival Recession, run by October 6 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 7 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 11 Jun 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?
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?
percentage of root coverage (time frame: 1 month, 3 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 11 Jun 2024.