Gingival RecessionNCT05270161
The Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment
A study testing Tunnel technique, Laterally closed tunnel technique and Free gingival graft in people with Gingival Recession, run by Universidade Federal de Alfenas at 1 site in Brazil.
Trial summary
The present study aims to compare the tunnel technique/laterally closed tunnel technique and the FGG technique in the treatment of isolate/multiple GR in the anterior region of the mandible. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Tunnel technique, Laterally closed tunnel technique and Free gingival graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Nov 2021to 5 Nov 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 60 years old;
- Present isolated (≥4mm) or multiple GR in the anterior region of the mandible (tooth 33 to 43) Miller Class I, II or III (87) (or Recession type (RT) 1 or RT2);
- Systemically healthy with no contraindications for periodontal surgery;
- Probing depth of less than 3mm at the sites involved;
- Selected teeth properly positioned, free from endodontic treatment, any type of restorative treatment, caries or non-carious cervical lesion
Who cannot join
- Participants who use tobacco or other types of drugs;
- Participants submitted to periodontal treatment in the last 6 months;
- Pregnant participants;
- Participants who did not accept to return to follow-ups;
- Participants who used antibiotics, corticosteroids, chemotherapy, immunomodulators or others that modify the periodontal therapy results during the last 6 months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Alfenas
Alfenas, Minas Gerais, 37130-013
Suzane C Pigossi, PhD, +55 (19) 981414158, suzane.pigossi@unifal-mg.edu.br
Suzane C Pigossi, PhD
About this study
Official title: Comparative Evaluation of the Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment: Randomized Controlled Trial
The present study aims to compare the tunnel technique/laterally closed tunnel technique and the FGG technique in the treatment of isolate/multiple GR in the anterior region of the mandible. Furthermore, it is proposed to evaluate the effect of a gel based on hyaluronic acid and green tea on the healing of the donor area after the removal of FGG from the palate. This work is expected to contribute to the still uncertain literature on the effectiveness of the tunnel technique as an alternative to the use of FGG in the treatment of multiple GR in the mandible.
Read the detailed description
Free gingival graft (FGG) is a simple technique considered the most effective procedure to obtain gingival augmentation in sites with a minimal amount of keratinized gingiva. However, the abscence of chromatic integration and unsatisfactory texture of the graft after healing prevent its use in areas with high aesthetic demand. In this context, the tunnel technique (multiple gingival recessions [GR]) and the laterally closed tunnel technique (isolated GRs in the mandible) have been proposed as an alternative to the use of FGG in the treatment of GRs in the mandible. The present study aims to compare the tunnel technique/laterally closed tunnel technique and the FGG technique in the treatment of isolate/multiple GR in the anterior region of the mandible. Furthermore, it is proposed to evaluate the effect of a gel based on hyaluronic acid and green tea on the healing of the donor area after the removal of FGG from the palate. Sixty participants presenting isolate/multiple Miller Class I, II, or III GR [Recession type (RT) 1 or RT2] in the anterior region of the mandible will be included in the present study. Regarding the treatment of GR, participants will be divided into four groups: (1) Test Group 1 (T1) (n=15): multiple GR in the anterior region of the mandible treated with the tunnel technique; (2) Test Group 2 (T2) (n=15): isolate GR in the anterior region of the mandible treated with the laterally closed tunnel technique; (3) Control Group 1 (C1) (n=15): multiple GRs in the anterior region of the mandible will be treated using the FGG technique and (4) Control Group 2 (C2) (n=15): isolate GRs in the anterior region of the mandible will be treated using the FGG technique. Regarding the treatment of the donor area, the same participants will be divided into two groups: (1) Gel Group (G) (n=30): the donor area on the palate will be treated using hyaluronic acid gel and green tea applied by the participant 3 times a day for 7 days; (2) Clot Group (CO) (n=30): No material will be placed in the donor area, only the clot will be kept in position by means of sutures. Periodontal clinical parameters will be evaluated in the receiving area at the beginning of the study and after 1, 3, 6 and 12 months postoperatively. In the donor area, the percentage of wound closure, the epithelialized surface area and the color of the palatine mucosa will be evaluated in both groups after 3, 7, 15 and 30 days. The visual analogue scale (VAS) of pain (donor and recipient area) and aesthetic (recipient area) will be used to assess the participant's perception of the treatment used.
- Conditions
- Gingival Recession
- Being tested
- Tunnel technique, Laterally closed tunnel technique, Free gingival graft, Gingival graft - donor area
- Keywords
- Gingival Recession, Esthetics, Gingiva
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunnel techniqueProcedure or surgery
Intrasulcular incisions on the buccal surface were made using a n°15 C blade, preserving the integrity of the papillae. The incision was extended to the adjacent tooth on both sides of the multiple recessions. Dissection of the entire buccal aspect was performed as a partial-thickness flap using sharp tunnel elevators preserving the papillae. The flap was extended beyond the mucogingival junction and under each papilla allowing a tension-free flap mobilization in the coronal direction. The connective tissue graft was placed in the tunnel and was stabilized using absorbable suspensory sutures. The mobilized mucous flap was advanced coronally to the cemento enamel junction, and suspensory sutures were stitched.
Laterally closed tunnel techniqueProcedure or surgery
Intrasulcular incisions on the buccal surface were made using a n°15 C blade, preserving the integrity of the papillae. The tunnel elevators were mobilized apically beyond the mucogingival line and extended medially and distally from the recession defect by undermining the facial surface of the interdental papillae. The insertion of muscles and fibers must be removed until a tension-free flap is obtained in the mesial, apical and distal directions. The preparation of the flap will be done carefully to avoid rupture of the papillae and perforation of the flap. As a result of this procedure, the mesial and distal margins of the flap must be brought together without tension to cover the exposed part of the root surface. The connective tissue graft was placed in the tunnel and was fixed mesially and distally at the inner aspect of the flap. Margins of the flap were pulled together over the graft and sutured with interrupted sutures.
Free gingival graftProcedure or surgery
In the recipient area, a marginal horizontal linear incision will be made in the mucogingival junction with a n°15 C blade, creating a partial thickness flap, keeping the periosteum intact. The horizontal dimension of the receiving area will be determined according to the mesiodistal extension of the area without keratinized gingiva. All mobile soft tissues, including epithelium, connective tissue and muscle fibers will be removed from the donor area using scissors to ensure stability in the recipient area. The connective tissue graft will be obtained by the free gingival graft technique and will be sutured in the recipient area.
Gingival graft - donor areaProcedure or surgery
The connective tissue graft will be obtained by the free gingival graft technique for all groups (T1, T2, T3 and T4). The mold of the prepared receiving area will be performed using sterile aluminum foil. The mold will be transferred to the donor area on the palate and the edges of the mold delimited with a scalpel blade. Deeper incisions will be made on the edges with the scalpel perpendicular to the palate, aiming to obtain a graft approximately 1.5 mm thick. With the scalpel blade parallel, the graft will be removed (epithelium and connective graft) maintaining its uniform thickness. For T1 and T2, the free gingival graft will be de-epithelialized. In donor area, a hyaluronic acid gel and green tea will be applied by the participant 3 times a day for 7 days (gel group) or no material will be placed in the donor area and the clot will be kept in position by means of sutures (clot group).
| Study group | Role | What they receive |
|---|---|---|
| Test Group 1 (T1) | Experimental | Multiple gingival recessions in the anterior region of the mandible treated with the tunnel technique. Receives: Procedure: Tunnel technique; Procedure: Gingival graft - donor area |
| Test Group 2 (T2) | Experimental | Isolate gingival recessions in the anterior region of the mandible treated with the laterally closed tunnel technique. Receives: Procedure: Laterally closed tunnel technique; Procedure: Gingival graft - donor area |
| Control Group 1 (C1) | Active comparator | Multiple gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique. Receives: Procedure: Free gingival graft; Procedure: Gingival graft - donor area |
| Control Group 2 (C2) | Active comparator | Isolate gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique. Receives: Procedure: Free gingival graft; Procedure: Gingival graft - donor area |
| Gel Group (G) | Experimental | The donor area on the palate will be treated using hyaluronic acid gel and green tea applied by the participant 3 times a day for 7 days. Receives: Procedure: Gingival graft - donor area |
| Clot Group (CO) | Active comparator | No material will be placed in the donor area, only the clot will be kept in position by means of sutures. Receives: Procedure: Gingival graft - donor area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession depth
Distance between cemento-enamel junction to free gingival margin.
Measured: Change from baseline recession depth at 1, 3, 6 and 12 months
Secondary outcomes (25)
Recession width
Mesio-distal extent of gingival recession
Measured: Change from baseline recession width at 1, 3, 6 and 12 months
Probing depth
Distance between free gingival margin to the bottom of the sulcus.
Measured: Change from baseline probing depth at 1, 3, 6 and 12 months
Clinical attachment level
Distance between cemento-enamel junction to the bottom of the sulcus.
Measured: Change from baseline clinical attachment level at 1, 3, 6 and 12 months
Keratinized tissue width
Distance between the most apical point on free gingival margin to the mucogingival junction.
Measured: Change from baseline keratinized tissue width at 1, 3, 6 and 12 months
Gingival thickness
The measurements were registered at the mid-buccal aspect of the tooth using a endodontic file. The distance between the marker and the tip of the file will be determined using a digital caliper.
Measured: Change from baseline gingival thickness at 6 and 12 months
Gingival margin position
Distance from a reference point performed on the customized stent to the gingival margin.
Measured: Change from baseline gingival margin position at 1, 3, 6 and 12 months
Graft thickness after removal
Graft thickness will be assessed immediately after removal using a endodontic file in the middle of the graft. The distance between the marker and the tip of the file will be determined using a digital caliper.
Measured: Baseline
Graft thickness immediately before suture
The thickness of the graft immediately before suturing will be evaluated after de-epithelialization (in the T group) and the removal of adipose tissue when present in both groups in the middle of the graft. The distance between the marker and the tip of the file will be determined using a digital caliper.
Measured: Baseline
Height of keratinized tissue in graft
Apico-coronal dimension of the graft measured at the stent mark using the periodontal probe.
Measured: Change from immediate postoperative height of keratinized tissue in graft at 1, 3, 6 and 12 months
Width of keratinized tissue in graft
Mesio-distal dimension of the graft in the most coronal portion of the graft using the periodontal probe.
Measured: Change from immediate postoperative width of keratinized tissue in graft at 1, 3, 6 and 12 months
Graft contraction
Graft areas will be calculated by multiplying the height and width of keratinized tissue in graft.
Measured: Change from immediate postoperative graft contraction at 1, 3, 6 and 12 months
Percentage of wound reduction by photographic image
The millimeter periodontal probe will be positioned next to the wound at the time of obtaining the photos to calibrate the image analysis software that will be used to calculate the total area of the wound in donor region.
Measured: Change from 3 days percentage of wound reduction by photographic image at 7, 15 and 30 days
Percentage of Wound Reduction by clinical measurement
The height and width of the wound will be determined using the periodontal probe.
Measured: Change from 3 days percentage of wound reduction by clinical measurement at 7, 15 and 30 days
Epithelized surface area
The epithelialization analysis will be performed using 3% oxygen peroxide to observe the presence of blistering in the wound. The absence of epithelialization will be characterized as blistering after contact of oxygen peroxide with the wound. This parameter will be noted dichotomously (presence/absence of bubbles), being noted as yes or no, respectively, in the participant's form.
Measured: Change from 3 days epithelized surface area at 7, 15 and 30 days
Palatal mucosa color
The color of the palatal mucosa will be evaluated by the visual analogue scale (VAS) in comparison with the color of the adjacent and opposite mucosa. In this evaluation, on a horizontal scale, 0 points will represent lack of color correspondence, 50 points will represent average correspondence and 100 points will represent excellent color correspondence with the adjacent tissues.
Measured: Change from 3 days palatal mucosa color at 7, 15 and 30 days
Postoperative complications
Presence of bleeding, swelling, infection and necrosis in the donor area will be recorded
Measured: 3 days
Postoperative complications
Presence of bleeding, swelling, infection and necrosis in the donor area will be recorded
Measured: 7 days
Landry index
Classify the degree of repair based on erythema, presence of granulation tissue, bleeding/suppuration, and epithelialization in the recipient area. A score of 1 to 5 is given, where 1 is associated with a very poor/inadequate repair process and 5 is excellent.
Measured: Change from 3 days landry index at 7 and 30 days
Root coverage esthetic score (RES)
The RES system evaluates five variables of the recipient area including: gingival margin level, marginal tissue contour, soft tissue texture, JMG alignment and gingival color. Zero, 3 or 6 points will be used to assess the position of the gingival margin, while a score of 0 or 1 point will be used for each of the other variables. The ideal aesthetic score will be 10.
Measured: 6 months
Root coverage esthetic score (RES)
The RES system evaluates five variables of the recipient area including: gingival margin level, marginal tissue contour, soft tissue texture, JMG alignment and gingival color. Zero, 3 or 6 points will be used to assess the position of the gingival margin, while a score of 0 or 1 point will be used for each of the other variables. The ideal aesthetic score will be 10.
Measured: 12 months
Visual Analogue Scale (VAS) for pain
The perception of pain will be recorded using the VAS scale at the operated sites. Participants will record the level of pain in the recipient and donor areas after the procedure on a horizontal scale, where the left endpoint will mean no pain (0), the midpoint of mean pain (50 ) and the right outcome severe pain (100).
Measured: Change from 3 days VAS scale for pain at 7, 12 and 30 days
Presence or absence of dentin sensitivity
Determined from the participants' responses regarding the presence or absence of sensitivity in the cervical sites. For this, it will be asked if the participant has or not dentin sensitivity after a cold or air stimulus.
Measured: Change from 1 month dentin sensitivity at 3, 6 and 12 months
Visual Analogue Scale (VAS) for esthetics
Participants will be asked to express their overall satisfaction with treatment outcomes on a VAS scale, where the left endpoint will mean not at all satisfied (0), the midpoint reasonably satisfied (50) and the right endpoint extremely satisfied. satisfied (100).
Measured: 6 months
Visual Analogue Scale (VAS) for esthetics
Participants will be asked to express their overall satisfaction with treatment outcomes on a VAS scale, where the left endpoint will mean not at all satisfied (0), the midpoint reasonably satisfied (50) and the right endpoint extremely satisfied. satisfied (100).
Measured: 12 months
Analgesics consumption
The consumption of analgesics by the participants in the first 7 postoperative days will also be recorded.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start5 Nov 2021
- Primary completion5 Nov 2025 (estimated)
- Study completion5 Nov 2025 (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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Alfenas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzane C Pigossi, PhD, Principal investigator, Alfenas Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270161
- Sponsor's protocol ID
- UFAlfenas
- Status last verified
- May 2024
- First submitted
- 31 Jan 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oliveira JA, da Silveira MI, de Oliveira Alves R, Bezerra FJB, de Oliveira GJPL, Pigossi SC. Effect of a gel containing green tea extract and hyaluronic acid on palate pain scores and wound healing after free gingival graft: a quasi-randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6735-6746. doi: 10.1007/s00784-023-05282-x. Epub 2023 Sep 29.
PubMed 37775584
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05270161
- Acronym / sponsor ID
- UFAlfenas
- Conditions
- Gingival Recession
- Keywords
- Gingival Recession, Esthetics, Gingiva
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Federal de AlfenasUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 5 Nov 2025 (estimated)
- Study completion
- 5 Nov 2025 (estimated)
- First posted
- 8 Mar 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.
The present study aims to compare the tunnel technique/laterally closed tunnel technique and the FGG technique in the treatment of isolate/multiple GR in the anterior region of the mandible. Furthermore, it is proposed to evaluate the effect of a gel based on hyaluronic acid and green tea on the healing of the donor area after the removal of FGG from the palate. This work is expected to contribute to the still uncertain literature on the effectiveness of the tunnel technique as an alternative to the use of FGG in the treatment of multiple GR in the mandible.
Detailed description
Free gingival graft (FGG) is a simple technique considered the most effective procedure to obtain gingival augmentation in sites with a minimal amount of keratinized gingiva. However, the abscence of chromatic integration and unsatisfactory texture of the graft after healing prevent its use in areas with high aesthetic demand. In this context, the tunnel technique (multiple gingival recessions [GR]) and the laterally closed tunnel technique (isolated GRs in the mandible) have been proposed as an alternative to the use of FGG in the treatment of GRs in the mandible. The present study aims to compare the tunnel technique/laterally closed tunnel technique and the FGG technique in the treatment of isolate/multiple GR in the anterior region of the mandible. Furthermore, it is proposed to evaluate the effect of a gel based on hyaluronic acid and green tea on the healing of the donor area after the removal of FGG from the palate. Sixty participants presenting isolate/multiple Miller Class I, II, or III GR [Recession type (RT) 1 or RT2] in the anterior region of the mandible will be included in the present study. Regarding the treatment of GR, participants will be divided into four groups: (1) Test Group 1 (T1) (n=15): multiple GR in the anterior region of the mandible treated with the tunnel technique; (2) Test Group 2 (T2) (n=15): isolate GR in the anterior region of the mandible treated with the laterally closed tunnel technique; (3) Control Group 1 (C1) (n=15): multiple GRs in the anterior region of the mandible will be treated using the FGG technique and (4) Control Group 2 (C2) (n=15): isolate GRs in the anterior region of the mandible will be treated using the FGG technique. Regarding the treatment of the donor area, the same participants will be divided into two groups: (1) Gel Group (G) (n=30): the donor area on the palate will be treated using hyaluronic acid gel and green tea applied by the participant 3 times a day for 7 days; (2) Clot Group (CO) (n=30): No material will be placed in the donor area, only the clot will be kept in position by means of sutures. Periodontal clinical parameters will be evaluated in the receiving area at the beginning of the study and after 1, 3, 6 and 12 months postoperatively. In the donor area, the percentage of wound closure, the epithelialized surface area and the color of the palatine mucosa will be evaluated in both groups after 3, 7, 15 and 30 days. The visual analogue scale (VAS) of pain (donor and recipient area) and aesthetic (recipient area) will be used to assess the participant's perception of the treatment used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Test Group 1 (T1) | Experimental | Procedure: Tunnel technique, Procedure: Gingival graft - donor areaMultiple gingival recessions in the anterior region of the mandible treated with the tunnel technique. |
| Test Group 2 (T2) | Experimental | Procedure: Laterally closed tunnel technique, Procedure: Gingival graft - donor areaIsolate gingival recessions in the anterior region of the mandible treated with the laterally closed tunnel technique. |
| Control Group 1 (C1) | Active comparator | Procedure: Free gingival graft, Procedure: Gingival graft - donor areaMultiple gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique. |
| Control Group 2 (C2) | Active comparator | Procedure: Free gingival graft, Procedure: Gingival graft - donor areaIsolate gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique. |
| Gel Group (G) | Experimental | Procedure: Gingival graft - donor areaThe donor area on the palate will be treated using hyaluronic acid gel and green tea applied by the participant 3 times a day for 7 days. |
| Clot Group (CO) | Active comparator | Procedure: Gingival graft - donor areaNo material will be placed in the donor area, only the clot will be kept in position by means of sutures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 60 years old;
- Present isolated (≥4mm) or multiple GR in the anterior region of the mandible (tooth 33 to 43) Miller Class I, II or III (87) (or Recession type (RT) 1 or RT2);
- Systemically healthy with no contraindications for periodontal surgery;
- Probing depth of less than 3mm at the sites involved;
- Selected teeth properly positioned, free from endodontic treatment, any type of restorative treatment, caries or non-carious cervical lesion
Key exclusion criteria (5 listed)
- Participants who use tobacco or other types of drugs;
- Participants submitted to periodontal treatment in the last 6 months;
- Pregnant participants;
- Participants who did not accept to return to follow-ups;
- Participants who used antibiotics, corticosteroids, chemotherapy, immunomodulators or others that modify the periodontal therapy results during the last 6 months.
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 |
|---|---|---|
| Tunnel techniqueIntrasulcular incisions on the buccal surface were made using a n°15 C blade, preserving the integrity of the papillae. The incision was extended to the adjacent tooth on both sides of the multiple recessions. Dissection of the entire buccal aspect was performed as a partial-thickness flap using sharp tunnel elevators preserving the papillae. The flap was extended beyond the mucogingival junction and under each papilla allowing a tension-free flap mobilization in the coronal direction. The connective tissue graft was placed in the tunnel and was stabilized using absorbable suspensory sutures. The mobilized mucous flap was advanced coronally to the cemento enamel junction, and suspensory sutures were stitched. | Procedure or surgery | Test Group 1 (T1) |
| Laterally closed tunnel techniqueIntrasulcular incisions on the buccal surface were made using a n°15 C blade, preserving the integrity of the papillae. The tunnel elevators were mobilized apically beyond the mucogingival line and extended medially and distally from the recession defect by undermining the facial surface of the interdental papillae. The insertion of muscles and fibers must be removed until a tension-free flap is obtained in the mesial, apical and distal directions. The preparation of the flap will be done carefully to avoid rupture of the papillae and perforation of the flap. As a result of this procedure, the mesial and distal margins of the flap must be brought together without tension to cover the exposed part of the root surface. The connective tissue graft was placed in the tunnel and was fixed mesially and distally at the inner aspect of the flap. Margins of the flap were pulled together over the graft and sutured with interrupted sutures. | Procedure or surgery | Test Group 2 (T2) |
| Free gingival graftIn the recipient area, a marginal horizontal linear incision will be made in the mucogingival junction with a n°15 C blade, creating a partial thickness flap, keeping the periosteum intact. The horizontal dimension of the receiving area will be determined according to the mesiodistal extension of the area without keratinized gingiva. All mobile soft tissues, including epithelium, connective tissue and muscle fibers will be removed from the donor area using scissors to ensure stability in the recipient area. The connective tissue graft will be obtained by the free gingival graft technique and will be sutured in the recipient area. | Procedure or surgery | Control Group 1 (C1), Control Group 2 (C2) |
| Gingival graft - donor areaThe connective tissue graft will be obtained by the free gingival graft technique for all groups (T1, T2, T3 and T4). The mold of the prepared receiving area will be performed using sterile aluminum foil. The mold will be transferred to the donor area on the palate and the edges of the mold delimited with a scalpel blade. Deeper incisions will be made on the edges with the scalpel perpendicular to the palate, aiming to obtain a graft approximately 1.5 mm thick. With the scalpel blade parallel, the graft will be removed (epithelium and connective graft) maintaining its uniform thickness. For T1 and T2, the free gingival graft will be de-epithelialized. In donor area, a hyaluronic acid gel and green tea will be applied by the participant 3 times a day for 7 days (gel group) or no material will be placed in the donor area and the clot will be kept in position by means of sutures (clot group). | Procedure or surgery | Clot Group (CO), Control Group 1 (C1), Control Group 2 (C2), Gel Group (G), Test Group 1 (T1), Test Group 2 (T2) |
Primary outcome
Recession depth
Time frame: Change from baseline recession depth at 1, 3, 6 and 12 months
Distance between cemento-enamel junction to free gingival margin.
25 secondary outcomes
Recession width
Time frame: Change from baseline recession width at 1, 3, 6 and 12 months
Probing depth
Time frame: Change from baseline probing depth at 1, 3, 6 and 12 months
Clinical attachment level
Time frame: Change from baseline clinical attachment level at 1, 3, 6 and 12 months
Keratinized tissue width
Time frame: Change from baseline keratinized tissue width at 1, 3, 6 and 12 months
Gingival thickness
Time frame: Change from baseline gingival thickness at 6 and 12 months
Gingival margin position
Time frame: Change from baseline gingival margin position at 1, 3, 6 and 12 months
Graft thickness after removal
Time frame: Baseline
Graft thickness immediately before suture
Time frame: Baseline
Height of keratinized tissue in graft
Time frame: Change from immediate postoperative height of keratinized tissue in graft at 1, 3, 6 and 12 months
Width of keratinized tissue in graft
Time frame: Change from immediate postoperative width of keratinized tissue in graft at 1, 3, 6 and 12 months
Graft contraction
Time frame: Change from immediate postoperative graft contraction at 1, 3, 6 and 12 months
Percentage of wound reduction by photographic image
Time frame: Change from 3 days percentage of wound reduction by photographic image at 7, 15 and 30 days
Percentage of Wound Reduction by clinical measurement
Time frame: Change from 3 days percentage of wound reduction by clinical measurement at 7, 15 and 30 days
Epithelized surface area
Time frame: Change from 3 days epithelized surface area at 7, 15 and 30 days
Palatal mucosa color
Time frame: Change from 3 days palatal mucosa color at 7, 15 and 30 days
Postoperative complications
Time frame: 3 days
Postoperative complications
Time frame: 7 days
Landry index
Time frame: Change from 3 days landry index at 7 and 30 days
Root coverage esthetic score (RES)
Time frame: 6 months
Root coverage esthetic score (RES)
Time frame: 12 months
Visual Analogue Scale (VAS) for pain
Time frame: Change from 3 days VAS scale for pain at 7, 12 and 30 days
Presence or absence of dentin sensitivity
Time frame: Change from 1 month dentin sensitivity at 3, 6 and 12 months
Visual Analogue Scale (VAS) for esthetics
Time frame: 6 months
Visual Analogue Scale (VAS) for esthetics
Time frame: 12 months
Analgesics consumption
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 37775584Oliveira JA, da Silveira MI, de Oliveira Alves R, Bezerra FJB, de Oliveira GJPL, Pigossi SC. Effect of a gel containing green tea extract and hyaluronic acid on palate pain scores and wound healing after free gingival graft: a quasi-randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6735-6746. doi: 10.1007/s00784-023-05282-x. Epub 2023 Sep 29.
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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.
Suzane C Pigossi, PhD principal investigator
Alfenas Federal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tunnel technique, Laterally closed tunnel technique and Free gingival graft in people with Gingival Recession, run by Universidade Federal de Alfenas 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 5 inclusion and 5 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 8 May 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 Suzane C Pigossi, PhD (+55 19 981414158, suzane.pigossi@unifal-mg.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession depth (time frame: Change from baseline recession depth at 1, 3, 6 and 12 months). 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 NCT05270161, 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 8 May 2024.