Root CoveragePhase 4NCT03690635
Root Coverage With Connective Tissue Graft Associated With VISTA Versus Tunnel Technique
A Phase 4 study testing VISTA (vestibular incision subperiosteal tunnel acess) in people with Root Coverage and Tunneling Technique, run by Cairo University.
Trial summary
Several techniques were proposed in the literature to solve the problems associated with gingival recession. Root coverage was mainly indicated for esthetic concern, however, it might also be indicated for treatment of root hypersensitivity and maintaining adequate plaque control by keratinized tissue augmentation. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Coverage, Tunneling Technique, VISTA Technique
- What is being tested?
- VISTA (vestibular incision subperiosteal tunnel acess)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2018to 10 Mar 2021
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients 18 years or older.
- Periodontally and systemically healthy.
- Presence of at least one Miller class I or II buccal gingival recession defect ≥1 and <6 mm in depth (Miller 1985)
- Teeth to be treated: Upper and lower central and lateral incisors, canine, first and second premolars, and first molar
- Full-mouth plaque and bleeding scores ≤ 20%, no pocket depths >3 mm, no active periodontal Disease.
- Clinical indication and/or patient request for recession coverage.
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- Radiographic evidence of sufficient interdental bone (i.e., the distance between the crestal bone and the cementoenamel junction is not greater than two mm)
- Gingival thickness of at least 0.5mm at a point located three mm below the free gingival margin.
- A minimum of two mm of keratinized gingiva (thick biotype).
Who cannot join
- Miller class III or IV recession defects.
- Thin biotype , gingival thickness less than or equal 0.5
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- Teeth with cervical restorations, abrasion.
- Patients unable to undergo minor oral surgical procedures.
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- Patients with a history of drug or alcohol abuse.
- Patients with a history of psychiatric disorder.
- Pregnant females.
- Uncontrolled periodontal disease or patient unwillingness to undergo needed periodontal therapy around remaining teeth.
- Patients who have any systemic condition that may contraindicate any other surgical procedures such as bleeding disorders, uncontrolled diabetes mellitus and immune compromised patients such as HIV patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Root Coverage With Connective Tissue Graft Associated With VISTA Versus Tunnel Technique in Miller Class I & II Recession Defects A Randomized Controlled Clinical Trial
Several techniques were proposed in the literature to solve the problems associated with gingival recession. Root coverage was mainly indicated for esthetic concern, however, it might also be indicated for treatment of root hypersensitivity and maintaining adequate plaque control by keratinized tissue augmentation.
These proposed surgical techniques were well-documented with successful outcomes. Each technique had its own advantages, disadvantages and indications. Various factors affected the most suitable technique. These factors were either related to the dimensions of gingival recession defect, or related to the surgeon experience or to the patient himself .
Read more
Nowadays, the scope of scientific research is concerned with designing surgical techniques that are more predictable, high esthetic, less invasive and patient centered In this way, continuous modification of surgical techniques aroused to result in a more reproducible outcomes; such as the attempt to advance pedicle flaps without vertical releasing incisions, as in the modified coronally advanced flap and the modified microsurgical tunnel technique.
However, controversy still exist in the literature regarding the best technique for root coverage. Coronally advanced flap is the most commonly reported technique in research, with lack of researches on tunneling techniques.
Read the detailed description
Nowadays, esthetic demands increased greatly where all seek a Hollywood smile with a white well-aligned teeth and pink healthy gingiva. Therefore, the demand on treatment of gingival recession increased. Since most gingival recession cases are generalized or involve multiple sites so, current research is focusing on how treatment of multiple recession defects can be efficient and less traumatic.
Several modifications of tunnel technique have been described in order to preserve esthetics, avoid relapse of gingival recession and maintain papillary integrity. These modifications also attend to avoid scar formation and delayed healing related to vertical releasing incision.
Although tunneling technique excluded vertical incisions with its drawbacks, tunneling was still a sensitive and a blind technique with increased trauma to sulcular epithelium which eventually resulted in unfavorable healing outcomes. So evolution of a newer approach known as Vestibular Incision Subperiosteal Tunnel Access (VISTA) was proposed to avoid some of the potential complications occurring with other intrasulcular tunneling techniques.
Moreover, a study by Cairo et al., 2009 reported increased incidence of post-operative pain and increased chair side time with tunneling in comparison to coronally advanced flap.
However, the evidence in literature is minimal on VISTA technique and there is no enough data comparing patient morbidity and root coverage outcomes between intrasulcular tunneling and vestibular tunneling except for few case reports. Therefore, this study aim to do a randomized clinical trial in order to assess the efficacy of VISTA technique in treatment of multiple gingival recession and compare it to tunneling technique.
The use of connective tissue graft seems to be a key of success in treatment of gingival recession regardless of the surgical technique used. Although there are numerous studies focusing on the effect of subepithelial connective tissue graft for the treatment of localized gingival recessions, but still more studies are needed to focus on the treatment of multiple recession defects.
Therefore, this study will monitor the effect of tunneling and VISTA techniques together with connective tissue graft on patient morbidity and root coverage outcomes.
- Conditions
- Root Coverage, Tunneling Technique, VISTA Technique, Sub Epithelial Connective Tissue Graft
- Being tested
- VISTA (vestibular incision subperiosteal tunnel acess)
- Keywords
- treatment of gingival recession, root coverage, tunneling technique, VISTA technique, sub epithelial connective tissue graft, recession treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISTA (vestibular incision subperiosteal tunnel acess)Procedure or surgery
Also called vestibular incision subperiosteal tunnel access
A vertical incision will be made on the mucous membrane and the periosteum with a scalpel. The incision will be 8-10mm long, beginning from the mobile mucosa and reaching the apical end of the keratinized gingiva.
A small subperiosteal elevator will be inserted through the incision and is used to free the subperiosteal tunnel flap. The flap includes the tissues of the mobile and immobile mucosa in the area of the affected teeth and about 1 mm distally and medially from them.
Subperiosteal tunnel will be extended interproximally under each papilla as far as the embrasure space permits, without making any surface incisions through the papilla.
Tunneling instruments will be used through the vertical incision to free the mucosa and the periosteum around the teeth affected by the gingival recession. This is continues at the base of the gingival papillae without affecting their integrity.
| Study group | Role | What they receive |
|---|---|---|
| VISTA technique | Experimental | evolution of a newer approach known as Vestibular Incision Subperiosteal Tunnel Access (VISTA) was proposed to avoid some of the potential complications occurring with other intrasulcular tunneling techniques Receives: Procedure: VISTA (vestibular incision subperiosteal tunnel acess) |
| tunneling technique | Active comparator | Several modifications of tunnel technique have been described in order to preserve esthetics, avoid relapse of gingival recession and maintain papillary integrity. These modifications also attend to avoid scar formation and delayed healing related to vertical releasing incision Receives: Procedure: VISTA (vestibular incision subperiosteal tunnel acess) |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative edema
post operative edema will be measured using visual analogue scale (VAS). Visual analogue scales (VAS) are used to measure the intensity or frequency of the symptoms and the pain. They are generally completed by patients themselves. The used scale in this study is a horizontal straight line of a fixed length (100 mm) and numbered every 10 mm ranging from "0 - no pain" to "100 - intolerable pain"
Measured: immediately post operative
Secondary outcomes (2)
Percentage of root coverage
Percentage of root coverage will be measured in millimeters using periodontal probe
Measured: 6 month
Root Coverage Esthetic Score
Score (Cairo et al., 2009)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start10 Oct 2018 (estimated)
- Primary completion10 Sep 2020 (estimated)
- Study completion10 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Root CoverageStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Gameel Mustafa Darweesh, Cairo University
- Investigators
- weam battawy, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690635
- Sponsor's protocol ID
- perio 0102051
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: i will check with the study chair
Publications
Gobbato L, Nart J, Bressan E, Mazzocco F, Paniz G, Lops D. Patient morbidity and root coverage outcomes after the application of a subepithelial connective tissue graft in combination with a coronally advanced flap or via a tunneling technique: a randomized controlled clinical trial. Clin Oral Investig. 2016 Nov;20(8):2191-2202. doi: 10.1007/s00784-016-1721-7. Epub 2016 Jan 27.
PubMed 26814715
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Coverage With Connective Tissue Graft Associated With VISTA Versus Tunnel Technique in Miller Class I & II Recession Defects A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03690635
- Acronym / sponsor ID
- perio 0102051
- Conditions
- Root Coverage, Tunneling Technique, VISTA Technique, Sub Epithelial Connective Tissue Graft
- Keywords
- treatment of gingival recession, root coverage, tunneling technique, VISTA technique, sub epithelial connective tissue graft, recession treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (estimated)
- Primary completion
- 10 Sep 2020 (estimated)
- Study completion
- 10 Mar 2021 (estimated)
- First posted
- 1 Oct 2018 (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.
Several techniques were proposed in the literature to solve the problems associated with gingival recession. Root coverage was mainly indicated for esthetic concern, however, it might also be indicated for treatment of root hypersensitivity and maintaining adequate plaque control by keratinized tissue augmentation.
These proposed surgical techniques were well-documented with successful outcomes. Each technique had its own advantages, disadvantages and indications. Various factors affected the most suitable technique. These factors were either related to the dimensions of gingival recession defect, or related to the surgeon experience or to the patient himself .
Nowadays, the scope of scientific research is concerned with designing surgical techniques that are more predictable, high esthetic, less invasive and patient centered In this way, continuous modification of surgical techniques aroused to result in a more reproducible outcomes; such as the attempt to advance pedicle flaps without vertical releasing incisions, as in the modified coronally advanced flap and the modified microsurgical tunnel technique.
However, controversy still exist in the literature regarding the best technique for root coverage. Coronally advanced flap is the most commonly reported technique in research, with lack of researches on tunneling techniques.
Detailed description
Nowadays, esthetic demands increased greatly where all seek a Hollywood smile with a white well-aligned teeth and pink healthy gingiva. Therefore, the demand on treatment of gingival recession increased. Since most gingival recession cases are generalized or involve multiple sites so, current research is focusing on how treatment of multiple recession defects can be efficient and less traumatic.
Several modifications of tunnel technique have been described in order to preserve esthetics, avoid relapse of gingival recession and maintain papillary integrity. These modifications also attend to avoid scar formation and delayed healing related to vertical releasing incision.
Although tunneling technique excluded vertical incisions with its drawbacks, tunneling was still a sensitive and a blind technique with increased trauma to sulcular epithelium which eventually resulted in unfavorable healing outcomes. So evolution of a newer approach known as Vestibular Incision Subperiosteal Tunnel Access (VISTA) was proposed to avoid some of the potential complications occurring with other intrasulcular tunneling techniques.
Moreover, a study by Cairo et al., 2009 reported increased incidence of post-operative pain and increased chair side time with tunneling in comparison to coronally advanced flap.
However, the evidence in literature is minimal on VISTA technique and there is no enough data comparing patient morbidity and root coverage outcomes between intrasulcular tunneling and vestibular tunneling except for few case reports. Therefore, this study aim to do a randomized clinical trial in order to assess the efficacy of VISTA technique in treatment of multiple gingival recession and compare it to tunneling technique.
The use of connective tissue graft seems to be a key of success in treatment of gingival recession regardless of the surgical technique used. Although there are numerous studies focusing on the effect of subepithelial connective tissue graft for the treatment of localized gingival recessions, but still more studies are needed to focus on the treatment of multiple recession defects.
Therefore, this study will monitor the effect of tunneling and VISTA techniques together with connective tissue graft on patient morbidity and root coverage outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISTA technique | Experimental | Procedure: VISTA (vestibular incision subperiosteal tunnel acess)evolution of a newer approach known as Vestibular Incision Subperiosteal Tunnel Access (VISTA) was proposed to avoid some of the potential complications occurring with other intrasulcular tunneling techniques |
| tunneling technique | Active comparator | Procedure: VISTA (vestibular incision subperiosteal tunnel acess)Several modifications of tunnel technique have been described in order to preserve esthetics, avoid relapse of gingival recession and maintain papillary integrity. These modifications also attend to avoid scar formation and delayed healing related to vertical releasing incision |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients 18 years or older.
- Periodontally and systemically healthy.
- Presence of at least one Miller class I or II buccal gingival recession defect ≥1 and <6 mm in depth (Miller 1985)
- Teeth to be treated: Upper and lower central and lateral incisors, canine, first and second premolars, and first molar
- Full-mouth plaque and bleeding scores ≤ 20%, no pocket depths >3 mm, no active periodontal Disease.
Key exclusion criteria (11 listed)
- Miller class III or IV recession defects.
- Thin biotype , gingival thickness less than or equal 0.5
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- Teeth with cervical restorations, abrasion.
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 |
|---|---|---|
| VISTA (vestibular incision subperiosteal tunnel acess)Also: vestibular incision subperiosteal tunnel accessA vertical incision will be made on the mucous membrane and the periosteum with a scalpel. The incision will be 8-10mm long, beginning from the mobile mucosa and reaching the apical end of the keratinized gingiva. A small subperiosteal elevator will be inserted through the incision and is used to free the subperiosteal tunnel flap. The flap includes the tissues of the mobile and immobile mucosa in the area of the affected teeth and about 1 mm distally and medially from them. Subperiosteal tunnel will be extended interproximally under each papilla as far as the embrasure space permits, without making any surface incisions through the papilla. Tunneling instruments will be used through the vertical incision to free the mucosa and the periosteum around the teeth affected by the gingival recession. This is continues at the base of the gingival papillae without affecting their integrity. | Procedure or surgery | VISTA technique, tunneling technique |
Primary outcome
post operative edema
Time frame: immediately post operative
post operative edema will be measured using visual analogue scale (VAS). Visual analogue scales (VAS) are used to measure the intensity or frequency of the symptoms and the pain. They are generally completed by patients themselves. The used scale in this study is a horizontal straight line of a fixed length (100 mm) and numbered every 10 mm ranging from "0 - no pain" to "100 - intolerable pain"
2 secondary outcomes
Percentage of root coverage
Time frame: 6 month
Root Coverage Esthetic Score
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Results publication: PubMed 26814715Gobbato L, Nart J, Bressan E, Mazzocco F, Paniz G, Lops D. Patient morbidity and root coverage outcomes after the application of a subepithelial connective tissue graft in combination with a coronally advanced flap or via a tunneling technique: a randomized controlled clinical trial. Clin Oral Investig. 2016 Nov;20(8):2191-2202. doi: 10.1007/s00784-016-1721-7. Epub 2016 Jan 27.
- Individual participant dataSharing planned: Undecided. i will check with the study chair
Related trials for Root Coverage
Recruiting
Free Mucogingival Graft for Isolated Root Coverage
Free Mucogingival Grafts, Gingival Recession
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.
weam battawy, PHD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VISTA (vestibular incision subperiosteal tunnel acess) in people with Root Coverage and Tunneling Technique, run by Cairo University.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mustafa Gameel, MSC (+201011183324, mustafagameel22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative edema (time frame: immediately post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690635, which also lists 1 linked publication.
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 1 Oct 2018; AzTrials last refreshed its copy on 30 Oct 2026.