Connective TissueNCT06365983
Comparison of Free Gingival Graft and Linear Incision for Connective Tissue
A study testing Connective Tissue with Free Gingival Graft and Connective Tissue with Linear Incision in people with Connective Tissue and Gingiva, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Connective Tissue, Gingiva, Gingival Recession
- What is being tested?
- Connective Tissue with Free Gingival Graft and Connective Tissue with Linear Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Apr 2023to 28 Apr 2026
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions.
Who cannot join
- Individuals will not be considered eligible if they:
- Present any form of immunological compromise;
- Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases;
- Present active periodontitis, defined by presence of >=10% subgingival bleeding and probing depth and clinical attachment loss proximal >4mm (Tonetti et al. 2018);
- Are current or ex-smokers;
- Have allergies to ibuprofen and chlorhexidine digluconate.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Alex Nogueira Haas
Porto Alegre, Rio Grande do Sul, 95780000
Cássio Cardona Orth, 11999791876, cassio.orth@gmail.com
About this study
Official title: Comparison of Free Gingival Graft and Linear Incision Techniques to Obtain Connective Tissue Graft in the Treatment of Multiple Gingival Recessions: a 12-month Non-inferiority Randomized Trial
A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons.
Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap (Zucchelli and De Sanctis) in both groups. The donor areas for connective tissue will be the hard palate region, with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side.
Read more
Each patient will undergo a preparatory phase for study inclusion, consisting of supragingival scaling, polishing, and oral hygiene instructions at least 3 weeks before study inclusion. Patients will be instructed on personalized and proper use of toothbrush, dental floss, and/or interdental brush.
All surgical procedures in both groups will be performed by the same operator (CCO). Randomization will determine the side to be operated on first. The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques.
Outcomes evaluated at 3, 6, 9, and 12 months include: gingival recession depth, probing depth, visible plaque, bleeding on probing, width of keratinized tissue, three-dimensional tissue assessment from intraoral scanning, and quality of life related. Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis.
INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions.
EXCLUSION CRITERIA
Individuals will not be considered eligible if they:
- Present any form of immunological compromise;
- Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases;
- Present active periodontitis, defined by presence of >=10% subgingival bleeding and probing depth and clinical attachment loss proximal >4mm (Tonetti et al. 2018);
- Are current or ex-smokers;
- Have allergies to ibuprofen and chlorhexidine digluconate.
Research Objective:
PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage.
SECONDARY OBJECTIVE
Compare the two grafts in terms of clinical outcomes of root coverage; Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography; Compare the two grafts in terms of patient-centered outcomes.
- Conditions
- Connective Tissue, Gingiva, Gingival Recession, Humans
- Being tested
- Connective Tissue with Free Gingival Graft, Connective Tissue with Linear Incision
- Keywords
- Free Gingival Graft, Linear Technique, 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.
Connective Tissue with Free Gingival GraftProcedure or surgery
The de-epithelialized free gingival grafting will begin with two horizontal incisions, 1.0 to 1.5 mm apical to the margin of the soft tissue of the adjacent teeth and two vertical incisions to delimit the area to be grafted. Along the coronal horizontal incision, the blade will be oriented almost perpendicular to the bone surface, and once an adequate thickness of soft tissue is obtained, it will be rotated to become almost parallel to the external surface of the palate. The graft thickness will be maintained uniform and the wound will be protected with absorbable collagen sponge derived from swine (Spongostan; Ethicon, Somerville, USA) and maintained with compressive sutures with non-absorbable 5-0 monofilament thread (Microsuture, São Paulo), anchored to the soft tissue apical to the area of the palatal wound. Immediately after suture completion, drops of high viscosity cyanoacrylate adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied.
Connective Tissue with Linear IncisionProcedure or surgery
The linear technique (Lorenzana ER, Allen EP 2000) will begin with a horizontal incision 2 mm apical to the gingival margin, perpendicular to the palate, which is deepened to the bone crest. Next, a second incision is made to divide the flap and expose the connective tissue bed. The thickness of the outer portion of the flap should be at least 1 mm, with uniformity throughout its extension to reduce the risk of epithelial tissue necrosis. Subsequently, internal lateral incisions (mesial and distal) and the base incision will be made, connecting the vertical incisions to delineate horizontal and vertical boundaries. Immediately after graft removal, an absorbable hemostatic collagen sponge derived from swine (Spongostan; Ethicon, Somerville, USA) will be placed and sutured using non-absorbable 5-0 monofilament thread (Microsuture, São Paulo).Immediately after suturing is completed, drops of high viscosity cyanoacrylate adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Free Gingival Graft | Active comparator | Not described Receives: Procedure: Connective Tissue with Free Gingival Graft |
| Linear Incision | Experimental | Not described Receives: Procedure: Connective Tissue with Linear Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of root coverage
Final minus baseline recession depth divided by baseline value
Measured: 12 months
Secondary outcomes (1)
Recession depth
Measurement from the cementoenamel junction to the most apical extension of the gingival margin
Measured: Baseline, 3, 6, 9 e 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start28 Apr 2023
- Primary completion28 Apr 2025 (estimated)
- Study completion28 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective TissueStudies 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
- Model description
- A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Nogueira Haas, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365983
- Sponsor's protocol ID
- UFRGS-Cassio
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Free Gingival Graft and Linear Incision Techniques to Obtain Connective Tissue Graft in the Treatment of Multiple Gingival Recessions: a 12-month Non-inferiority Randomized Trial
- ClinicalTrials.gov ID
- NCT06365983
- Acronym / sponsor ID
- UFRGS-Cassio
- Conditions
- Connective Tissue, Gingiva, Gingival Recession, Humans
- Keywords
- Free Gingival Graft, Linear Technique, Root Coverage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 28 Apr 2026 (estimated)
- First posted
- 15 Apr 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.
A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons.
Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap (Zucchelli and De Sanctis) in both groups. The donor areas for connective tissue will be the hard palate region, with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side.
Each patient will undergo a preparatory phase for study inclusion, consisting of supragingival scaling, polishing, and oral hygiene instructions at least 3 weeks before study inclusion. Patients will be instructed on personalized and proper use of toothbrush, dental floss, and/or interdental brush.
All surgical procedures in both groups will be performed by the same operator (CCO). Randomization will determine the side to be operated on first. The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques.
Outcomes evaluated at 3, 6, 9, and 12 months include: gingival recession depth, probing depth, visible plaque, bleeding on probing, width of keratinized tissue, three-dimensional tissue assessment from intraoral scanning, and quality of life related. Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis.
INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions.
EXCLUSION CRITERIA
Individuals will not be considered eligible if they:
- Present any form of immunological compromise;
- Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases;
- Present active periodontitis, defined by presence of >=10% subgingival bleeding and probing depth and clinical attachment loss proximal >4mm (Tonetti et al. 2018);
- Are current or ex-smokers;
- Have allergies to ibuprofen and chlorhexidine digluconate.
Research Objective:
PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage.
SECONDARY OBJECTIVE
Compare the two grafts in terms of clinical outcomes of root coverage; Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography; Compare the two grafts in terms of patient-centered outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons.
| Arm | Type | Receives |
|---|---|---|
| Free Gingival Graft | Active comparator | Procedure: Connective Tissue with Free Gingival Graft |
| Linear Incision | Experimental | Procedure: Connective Tissue with Linear Incision |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions.
Key exclusion criteria (6 listed)
- Present any form of immunological compromise;
- Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases;
- Present active periodontitis, defined by presence of >=10% subgingival bleeding and probing depth and clinical attachment loss proximal >4mm (Tonetti et al. 2018);
- Are current or ex-smokers;
- Have allergies to ibuprofen and chlorhexidine digluconate.
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 |
|---|---|---|
| Connective Tissue with Free Gingival GraftThe de-epithelialized free gingival grafting will begin with two horizontal incisions, 1.0 to 1.5 mm apical to the margin of the soft tissue of the adjacent teeth and two vertical incisions to delimit the area to be grafted. Along the coronal horizontal incision, the blade will be oriented almost perpendicular to the bone surface, and once an adequate thickness of soft tissue is obtained, it will be rotated to become almost parallel to the external surface of the palate. The graft thickness will be maintained uniform and the wound will be protected with absorbable collagen sponge derived from swine (Spongostan; Ethicon, Somerville, USA) and maintained with compressive sutures with non-absorbable 5-0 monofilament thread (Microsuture, São Paulo), anchored to the soft tissue apical to the area of the palatal wound. Immediately after suture completion, drops of high viscosity cyanoacrylate adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied. | Procedure or surgery | Free Gingival Graft |
| Connective Tissue with Linear IncisionThe linear technique (Lorenzana ER, Allen EP 2000) will begin with a horizontal incision 2 mm apical to the gingival margin, perpendicular to the palate, which is deepened to the bone crest. Next, a second incision is made to divide the flap and expose the connective tissue bed. The thickness of the outer portion of the flap should be at least 1 mm, with uniformity throughout its extension to reduce the risk of epithelial tissue necrosis. Subsequently, internal lateral incisions (mesial and distal) and the base incision will be made, connecting the vertical incisions to delineate horizontal and vertical boundaries. Immediately after graft removal, an absorbable hemostatic collagen sponge derived from swine (Spongostan; Ethicon, Somerville, USA) will be placed and sutured using non-absorbable 5-0 monofilament thread (Microsuture, São Paulo).Immediately after suturing is completed, drops of high viscosity cyanoacrylate adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied. | Procedure or surgery | Linear Incision |
Primary outcome
Percentage of root coverage
Time frame: 12 months
Final minus baseline recession depth divided by baseline value
1 secondary outcome
Recession depth
Time frame: Baseline, 3, 6, 9 e 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective Tissue with Free Gingival Graft and Connective Tissue with Linear Incision in people with Connective Tissue and Gingiva, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Apr 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cássio Cardona Orth, Msc (11999791876, cassio.orth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of root coverage (time frame: 12 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 15 Apr 2024.