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The Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment

Primary Purpose

Gingival Recession

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tunnel technique
Laterally closed tunnel technique
Free gingival graft
Gingival graft - donor area
Sponsored by
Universidade Federal de Alfenas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Gingival Recession, Esthetics, Gingiva

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Universidade Federal de AlfenasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Experimental

Active Comparator

Arm Label

Test Group 1 (T1)

Test Group 2 (T2)

Control Group 1 (C1)

Control Group 2 (C2)

Gel Group (G)

Clot Group (CO)

Arm Description

Multiple gingival recessions in the anterior region of the mandible treated with the tunnel technique.

Isolate gingival recessions in the anterior region of the mandible treated with the laterally closed tunnel technique.

Multiple gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique.

Isolate gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique.

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.

No material will be placed in the donor area, only the clot will be kept in position by means of sutures.

Outcomes

Primary Outcome Measures

Recession depth
Distance between cemento-enamel junction to free gingival margin.

Secondary Outcome Measures

Recession width
Mesio-distal extent of gingival recession
Probing depth
Distance between free gingival margin to the bottom of the sulcus.
Clinical attachment level
Distance between cemento-enamel junction to the bottom of the sulcus.
Keratinized tissue width
Distance between the most apical point on free gingival margin to the mucogingival junction.
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.
Gingival margin position
Distance from a reference point performed on the customized stent to the gingival margin.
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.
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.
Height of keratinized tissue in graft
Apico-coronal dimension of the graft measured at the stent mark using the periodontal probe.
Width of keratinized tissue in graft
Mesio-distal dimension of the graft in the most coronal portion of the graft using the periodontal probe.
Graft contraction
Graft areas will be calculated by multiplying the height and width of keratinized tissue in graft.
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.
Percentage of Wound Reduction by clinical measurement
The height and width of the wound will be determined using the periodontal probe.
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.
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.
Postoperative complications
Presence of bleeding, swelling, infection and necrosis in the donor area will be recorded
Postoperative complications
Presence of bleeding, swelling, infection and necrosis in the donor area will be recorded
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.
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.
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.
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).
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.
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).
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).
Analgesics consumption
The consumption of analgesics by the participants in the first 7 postoperative days will also be recorded.

Full Information

First Posted
January 31, 2022
Last Updated
February 25, 2022
Sponsor
Universidade Federal de Alfenas
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1. Study Identification

Unique Protocol Identification Number
NCT05270161
Brief Title
The Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment
Official Title
Comparative Evaluation of the Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
November 5, 2025 (Anticipated)
Study Completion Date
November 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Federal de Alfenas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Gingival Recession, Esthetics, Gingiva

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group 1 (T1)
Arm Type
Experimental
Arm Description
Multiple gingival recessions in the anterior region of the mandible treated with the tunnel technique.
Arm Title
Test Group 2 (T2)
Arm Type
Experimental
Arm Description
Isolate gingival recessions in the anterior region of the mandible treated with the laterally closed tunnel technique.
Arm Title
Control Group 1 (C1)
Arm Type
Active Comparator
Arm Description
Multiple gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique.
Arm Title
Control Group 2 (C2)
Arm Type
Active Comparator
Arm Description
Isolate gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique.
Arm Title
Gel Group (G)
Arm Type
Experimental
Arm Description
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.
Arm Title
Clot Group (CO)
Arm Type
Active Comparator
Arm Description
No material will be placed in the donor area, only the clot will be kept in position by means of sutures.
Intervention Type
Procedure
Intervention Name(s)
Tunnel technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laterally closed tunnel technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Free gingival graft
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gingival graft - donor area
Intervention Description
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).
Primary Outcome Measure Information:
Title
Recession depth
Description
Distance between cemento-enamel junction to free gingival margin.
Time Frame
Change from baseline recession depth at 1, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Recession width
Description
Mesio-distal extent of gingival recession
Time Frame
Change from baseline recession width at 1, 3, 6 and 12 months
Title
Probing depth
Description
Distance between free gingival margin to the bottom of the sulcus.
Time Frame
Change from baseline probing depth at 1, 3, 6 and 12 months
Title
Clinical attachment level
Description
Distance between cemento-enamel junction to the bottom of the sulcus.
Time Frame
Change from baseline clinical attachment level at 1, 3, 6 and 12 months
Title
Keratinized tissue width
Description
Distance between the most apical point on free gingival margin to the mucogingival junction.
Time Frame
Change from baseline keratinized tissue width at 1, 3, 6 and 12 months
Title
Gingival thickness
Description
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.
Time Frame
Change from baseline gingival thickness at 6 and 12 months
Title
Gingival margin position
Description
Distance from a reference point performed on the customized stent to the gingival margin.
Time Frame
Change from baseline gingival margin position at 1, 3, 6 and 12 months
Title
Graft thickness after removal
Description
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.
Time Frame
Baseline
Title
Graft thickness immediately before suture
Description
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.
Time Frame
Baseline
Title
Height of keratinized tissue in graft
Description
Apico-coronal dimension of the graft measured at the stent mark using the periodontal probe.
Time Frame
Change from immediate postoperative height of keratinized tissue in graft at 1, 3, 6 and 12 months
Title
Width of keratinized tissue in graft
Description
Mesio-distal dimension of the graft in the most coronal portion of the graft using the periodontal probe.
Time Frame
Change from immediate postoperative width of keratinized tissue in graft at 1, 3, 6 and 12 months
Title
Graft contraction
Description
Graft areas will be calculated by multiplying the height and width of keratinized tissue in graft.
Time Frame
Change from immediate postoperative graft contraction at 1, 3, 6 and 12 months
Title
Percentage of wound reduction by photographic image
Description
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.
Time Frame
Change from 3 days percentage of wound reduction by photographic image at 7, 15 and 30 days
Title
Percentage of Wound Reduction by clinical measurement
Description
The height and width of the wound will be determined using the periodontal probe.
Time Frame
Change from 3 days percentage of wound reduction by clinical measurement at 7, 15 and 30 days
Title
Epithelized surface area
Description
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.
Time Frame
Change from 3 days epithelized surface area at 7, 15 and 30 days
Title
Palatal mucosa color
Description
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.
Time Frame
Change from 3 days palatal mucosa color at 7, 15 and 30 days
Title
Postoperative complications
Description
Presence of bleeding, swelling, infection and necrosis in the donor area will be recorded
Time Frame
3 days
Title
Postoperative complications
Description
Presence of bleeding, swelling, infection and necrosis in the donor area will be recorded
Time Frame
7 days
Title
Landry index
Description
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.
Time Frame
Change from 3 days landry index at 7 and 30 days
Title
Root coverage esthetic score (RES)
Description
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.
Time Frame
6 months
Title
Root coverage esthetic score (RES)
Description
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.
Time Frame
12 months
Title
Visual Analogue Scale (VAS) for pain
Description
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).
Time Frame
Change from 3 days VAS scale for pain at 7, 12 and 30 days
Title
Presence or absence of dentin sensitivity
Description
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.
Time Frame
Change from 1 month dentin sensitivity at 3, 6 and 12 months
Title
Visual Analogue Scale (VAS) for esthetics
Description
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).
Time Frame
6 months
Title
Visual Analogue Scale (VAS) for esthetics
Description
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).
Time Frame
12 months
Title
Analgesics consumption
Description
The consumption of analgesics by the participants in the first 7 postoperative days will also be recorded.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzane C Pigossi, PhD
Phone
+55 19 981414158
Email
suzane.pigossi@unifal-mg.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzane C Pigossi, PhD
Organizational Affiliation
Alfenas Federal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Alfenas
City
Alfenas
State/Province
Minas Gerais
ZIP/Postal Code
37130-013
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzane C Pigossi, PhD
Phone
+55 (19) 981414158
Email
suzane.pigossi@unifal-mg.edu.br
First Name & Middle Initial & Last Name & Degree
Suzane C Pigossi, PhD
First Name & Middle Initial & Last Name & Degree
Guilherme PL de Oliveira, PhD
First Name & Middle Initial & Last Name & Degree
Jovânia A Oliveira
First Name & Middle Initial & Last Name & Degree
Marcela I Silveira
First Name & Middle Initial & Last Name & Degree
Roberta O Alves

12. IPD Sharing Statement

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The Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment

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