Cross-linked Hyaluronic AcidNCT05436002
Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial
A study testing With Cross-linked Hyaluronic Acid in people with Cross-linked Hyaluronic Acid, run by University of Lisbon.
Trial summary
To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cross-linked Hyaluronic Acid
- What is being tested?
- With Cross-linked Hyaluronic Acid
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2022to 15 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- None of the patients were smokers and all were systemically healthy without any signs of periodontal disease.
- Each patient had to display at least one ginvigal recession (RT1) of a depth of ≥ 2 mm.
- Patients exhibited an adequate level of oral hygiene evidenced by a full- mouth plaque score (FMPS) < 25%39 and full-mouth bleeding score (FMBS) < 25%.
Who cannot join
- Smokers
- Gingival recesstion RT 2 or RT 3 (Cairo 2011).
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.
Read the detailed description
To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.
To evaluate the esthetic outcome as perceived by periodontists, using the root coverage esthetic score (RES).
Test Group - Tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.
Control Group - Tunnel technique and subepithelial palatal connective tissue grafts.
- Conditions
- Cross-linked Hyaluronic Acid
- Being tested
- With Cross-linked Hyaluronic Acid
- Keywords
- cross-linked hyaluronic acid, tunnel technique, gingival recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With Cross-linked Hyaluronic AcidDevice
Without Cross-linked Hyaluronic Acid
| Study group | Role | What they receive |
|---|---|---|
| With Cross-linked Hyaluronic Acid | Active comparator | Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. Receives: Device: With Cross-linked Hyaluronic Acid |
| Whitout Cross-linked Hyaluronic Acid | Placebo comparator | Tunnel Technique in Conjunction With Subepithelial Connective Tissue Graft. Receives: Device: With Cross-linked Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival margin
Score 0: failure of root coverage (gingival margin apical or equal to the baseline recession); Score 3: partial root coverage; Score 6: complete root coverage with no detectable CEJ.
Measured: 6 month after surgery
Marginal tissue contour
Score 0: irregular gingival margin (it does not follow CEJ); Score 1: proper marginal contour/scalloped gingival margin (following CEJ).
Measured: 6 month after surgery
Soft tissue texture
Score 0: presence of scar formation and/or keloid-like appearance; Score 1: absence of scar or keloid formation.
Measured: 6 month after surgery
Mucogingival junction
Score 0: MGJ not aligned with MGJ on adjacent teeth; Score 1: MGJ aligned with MGJ on adjacent teeth.
Measured: 6 month after surgery
Gingival color
Score 0: color of tissue differs from gingival color on adjacent teeth; Score 1: normal color and integration with the adjacent soft tissues.
Measured: 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start15 Oct 2022 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross-linked Hyaluronic AcidStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Rocha Rodrigues, University of Lisbon
- Investigators
- Vanessa Rodrigues, Dr, Principal investigator, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436002
- Sponsor's protocol ID
- Cross-linked hyaluronic acid
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05436002
- Acronym / sponsor ID
- Cross-linked hyaluronic acid
- Conditions
- Cross-linked Hyaluronic Acid
- Keywords
- cross-linked hyaluronic acid, tunnel technique, gingival recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 28 Jun 2022 (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.
To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.
Detailed description
To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.
To evaluate the esthetic outcome as perceived by periodontists, using the root coverage esthetic score (RES).
Test Group - Tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.
Control Group - Tunnel technique and subepithelial palatal connective tissue grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Cross-linked Hyaluronic Acid | Active comparator | Device: With Cross-linked Hyaluronic AcidTunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. |
| Whitout Cross-linked Hyaluronic Acid | Placebo comparator | Device: With Cross-linked Hyaluronic AcidTunnel Technique in Conjunction With Subepithelial Connective Tissue Graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- None of the patients were smokers and all were systemically healthy without any signs of periodontal disease.
- Each patient had to display at least one ginvigal recession (RT1) of a depth of ≥ 2 mm.
- Patients exhibited an adequate level of oral hygiene evidenced by a full- mouth plaque score (FMPS) < 25%39 and full-mouth bleeding score (FMBS) < 25%.
Key exclusion criteria (2 listed)
- Smokers
- Gingival recesstion RT 2 or RT 3 (Cairo 2011).
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 |
|---|---|---|
| With Cross-linked Hyaluronic AcidWithout Cross-linked Hyaluronic Acid | Device | Whitout Cross-linked Hyaluronic Acid, With Cross-linked Hyaluronic Acid |
Primary outcome
Gingival margin
Time frame: 6 month after surgery
Score 0: failure of root coverage (gingival margin apical or equal to the baseline recession); Score 3: partial root coverage; Score 6: complete root coverage with no detectable CEJ.
Marginal tissue contour
Time frame: 6 month after surgery
Score 0: irregular gingival margin (it does not follow CEJ); Score 1: proper marginal contour/scalloped gingival margin (following CEJ).
Soft tissue texture
Time frame: 6 month after surgery
Score 0: presence of scar formation and/or keloid-like appearance; Score 1: absence of scar or keloid formation.
Mucogingival junction
Time frame: 6 month after surgery
Score 0: MGJ not aligned with MGJ on adjacent teeth; Score 1: MGJ aligned with MGJ on adjacent teeth.
Gingival color
Time frame: 6 month after surgery
Score 0: color of tissue differs from gingival color on adjacent teeth; Score 1: normal color and integration with the adjacent soft tissues.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Cross-linked Hyaluronic Acid
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Not yet recruiting
HYAcorp MLF1 Hyaluronic Acid Filler for Penile Girth Enhancement
Penile Girth Enhancement
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Active, not recruiting
Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
Photoaging
Not yet recruitingPhase 1/2
Evaluation of NIPSA Using Alloplastic Bone Graft and Cross-Linked Hyaluronic Acid in theTreatment of Intrabony Defects
Intrabony Periodontal Defect, Periodontal Disease
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.
Vanessa Rodrigues, Dr principal investigator
University of Lisbon
Questions about this trial
What is this clinical trial studying?
A study testing With Cross-linked Hyaluronic Acid in people with Cross-linked Hyaluronic Acid, run by University of Lisbon.
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 3 inclusion and 2 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 28 Jun 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Rodrigues, Dr (919950890 ext. +351, Vanessa_15_rodrigues@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival margin (time frame: 6 month after surgery). The study lists 5 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 28 Jun 2022.