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Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg

Primary Purpose

Palate; Wound

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
DFGG
SCTG
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palate; Wound

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with at least 18 years Systemically healthy Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of < 15% Non-smokers or smokers of ≤ 10 cigarettes per day Indication of mucogingival surgery in teeth and/or implants. Exclusion Criteria: Smokers ≥ 10 cigarettes per day General contraindications for surgery Medications known to affect the gingiva or interfere with wound healing Pregnancy Benzodiazepines and/or analgesics intake Patients nos systemically healthy or uncontrolled (i.e: Diabetes, inmunosuppresed)

Sites / Locations

  • Universidad Internacional de CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Depithelised Free Gingival Graft, DFGG

Subepithelial Connective Tissue Graft, SCTG

Arm Description

The group assignment was communicated through a sealed envelope that was opened just prior to the surgery. The subjects will undergo to a harvesting procedure of a palatal graft using DFGG technique described as following: two horizontal and two vertical incisions will be traced with a 15C blade to delimit the area to be grafted. Along the coronal horizontal incision, the blade will be oriented almost perpendicular to the bone plate and once an adequate soft tissue thickness was obtained, it will be rotated in order to be almost parallel to the superficial surface. The thickness of the graft will be maintained uniform while proceeding apically with the blade. Once the graft is separated, the adipose and glandular tissue as well as the epithelium will be removed extra orally with a new blade. Finally the palate will be sutured with 5-0 monofilament suture and collagen sponges. In this group the palate is suppose to have a secondary intention healing.

The group assignment was communicated through a sealed envelope that was opened just prior to the surgery. The subjects will undergo to a harvesting procedure of a palatal graft using SCTG technique described as following: one deep horizontal incision parallel to the gingival margin will be traced at 1.5 mm apical to the gingival margin of the adjacent teeth, according to the palatal pocket depth of the teeth. A deeper incision parallel and deeper to the initial one will be performed. The primary flap will be elevated split-thickness. The horizontal incision will be made almost perpendicular to the underlying bone. Once an adequate soft tissue thickness is obtained, the blade will be rotated in order to be almost parallel to the external surface. The thickness of the graft will be maintained uniform. Finally the palate will be sutured with 5-0 monofilament suture and collagen sponges.In this group the palate is suppose to have a primary intention healing.

Outcomes

Primary Outcome Measures

Volumetric changes during wound healing
Volumetric differences of the harvested site between baseline (prior to the intervention) and every following recall will be assessed. Intraoral scans will be registered at baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention during healing. The results will be elaborated superimposing the STL files registered at very time points using Geomagic software (3d systems). The software will output a descriptive statistics: mean volumetric difference, Minimum, Maximum, Variance.

Secondary Outcome Measures

Patients pain perception
To evaluate the postoperative pain, patients were instructed to to fill a questionnaire at every time point. The questionnaire consisted of a 100-mm Visual Analog Scale (VAS) describing the level of pain experienced on the palatal site from 0 to 10, with 10 being the worst pain ever experience, and 0 no pain.
Analgesics Intake
Post-operative pain was indirectly evaluated on the basis of the mean mg (milligrams) consumption of analgesics (ibuprofene).
Histological Analysis
Tissue samples (1 × 1 × 5 mm) harvested will be fixed in buffered 4% formaldehyde overnight. After a routine preparation for paraffin embedment including tissue immersion in a series of alcohol baths at different concentrations, the specimens will be sectioned (3 μm) with a Rotatory Microtome CUT4062 and stained with hematoxylin-eosin. The obtained sections will be examined using a Leica DMR microscope and photographed with a Leica DFC 320 digital camera. The histo-morphometrical analysis will be conducted using an image processing software with the assessment of total area of the sample (TAS), area of epithelium (AE), area of lamina propria (ALP), area of submucosa (ASM), and the average epithelium thickness (ET) measured in three different locations in each sample.
Immunohistoquemical Analysis of S100 protein
S100 protein is characteristic of nervous tissues cells. This analysis aim to compare the subjective pain perception of other outcomes with the quantity of nervous cells found in the graft. Sections will be cut, dewaxed and rehydrated. Antibodies, along with their dilutions and sources. For antigen retrieval, heat treatments will be applied (95°C, 8 min in cell conditioning solution 1 for Glut1, calretinin and S100, and cell conditioning solution 2 for Map2) prior to the primary antibody reactions. A Tris-based buffer solution (pH 7.6 ± 0.2) was used. After UV inhibition, primary antibody reactions will be performed, in addition to counterstaining with haematoxylin. Neurone specific enolase staining will be performed. The immuno-histoquemical analysis will be conducted using an image processing software with the assessment of total area of the sample in order to count ganglia and neurons in an area of up to five high power fields in relation to it.
Graft dimension accuracy
Graft dimensions accuracy (GDA): It will be assessed comparing GD0, the needed dimensions of the graft (x0=length, y0= height, z0= thickness), registered in advanced, with GD1, the actual dimensions of the harvested graft (x1=length, y1= height, z1= thickness).
post-srugical pain
the following questions, both assessed at every recall. (1) Did you take any more painkillers due to the palatal pain since the procedure was completed? (2) If necessary, would you repeat the palatal harvesting procedure? (3) Did you have any unexpected post-operative incidence? Whenever the patient stopped to take analgesics the measurement of this outcome will be interrupted. Being answered by yes or no.

Full Information

First Posted
February 16, 2023
Last Updated
April 12, 2023
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05828394
Brief Title
Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg
Official Title
Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

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

5. Study Description

Brief Summary
A single blinded randomized clinical trial was designed to evaluate the influence of palatal harvesting technique on post-operatory patient pain perception. The participants will be selected between subjects in need of at least one mucogingival procedure involving the harvesting of a connective tissue graft and then randomly allocated in the following groups. Two harvesting techniques were chosen to be compared: de-epithelialized free gingival graft (DFGG) and subepithelial connective tissue graft (SCTG).
Detailed Description
To evaluate the postoperative pain, patients were instructed to complete a 100-mm VAS and classify the level of pain experienced on the palatal site from 0 to 10, with 10 being the worst pain ever experience. Analgesics intake (AI): Post-operative pain was indirectly evaluated on the basis of the mean mg consumption of analgesics (ibuprofene). Post operative complications (PC): To evaluate the excessive bleeding., patients were instructed to complete a 100-mm VAS and classify the level of bleeding experienced on the palatal site from 0 to 10. Dimensions of the needed graft (GD0): (x0=length, y0=height, z0=thickness) it will be measured once prepared the recipient site. Dimensions of the harvested graft (GD1): (x1=length, y1=height, z1=thickness) it will be measured with a calliper calibrated in mm just after the harvesting. Surgical time (T): time required from harvesting the graft till the suture of the donor site. Intra surgical complications (IP): perforations of the palatal flap (in the case of the SCTG) and arterial bleeding will be registered and counted as intra-surgical complications. The following parameters will be calculated: Palatal volume changes (V changes): Volumetric differences between the intraoral scans of baseline and at every following recall will be assessed with the aim of software (Geomagic by 3d systems). Superimposing the STL files using the teeth as fixed reference points will allow to measure differences in volume changes. Graft dimensions accuracy (GDA): It will be assessed comparing GD0, the needed dimensions of the graft (x0=length, y0= height, z0= thickness) with GD1, the actual dimensions of the harvested graft (x1=length, y1= height, z1= thickness). Mean baseline thickness of the palatal soft tissues (mT0): It will be measured superimposing the cbct with the intraoral scan at baseline. The measurements will be performed using a implant planning software. Mean final thickness of the palatal soft tissues (mT1): It will be measured superimposing the cbct with the intraoral scan at 12 weeks. The measurements will be performed using a implant planning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palate; Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Depithelised Free Gingival Graft, DFGG
Arm Type
Experimental
Arm Description
The group assignment was communicated through a sealed envelope that was opened just prior to the surgery. The subjects will undergo to a harvesting procedure of a palatal graft using DFGG technique described as following: two horizontal and two vertical incisions will be traced with a 15C blade to delimit the area to be grafted. Along the coronal horizontal incision, the blade will be oriented almost perpendicular to the bone plate and once an adequate soft tissue thickness was obtained, it will be rotated in order to be almost parallel to the superficial surface. The thickness of the graft will be maintained uniform while proceeding apically with the blade. Once the graft is separated, the adipose and glandular tissue as well as the epithelium will be removed extra orally with a new blade. Finally the palate will be sutured with 5-0 monofilament suture and collagen sponges. In this group the palate is suppose to have a secondary intention healing.
Arm Title
Subepithelial Connective Tissue Graft, SCTG
Arm Type
Experimental
Arm Description
The group assignment was communicated through a sealed envelope that was opened just prior to the surgery. The subjects will undergo to a harvesting procedure of a palatal graft using SCTG technique described as following: one deep horizontal incision parallel to the gingival margin will be traced at 1.5 mm apical to the gingival margin of the adjacent teeth, according to the palatal pocket depth of the teeth. A deeper incision parallel and deeper to the initial one will be performed. The primary flap will be elevated split-thickness. The horizontal incision will be made almost perpendicular to the underlying bone. Once an adequate soft tissue thickness is obtained, the blade will be rotated in order to be almost parallel to the external surface. The thickness of the graft will be maintained uniform. Finally the palate will be sutured with 5-0 monofilament suture and collagen sponges.In this group the palate is suppose to have a primary intention healing.
Intervention Type
Procedure
Intervention Name(s)
DFGG
Intervention Description
Depithelised free gingival graft harvesting technique
Intervention Type
Procedure
Intervention Name(s)
SCTG
Intervention Description
Subepithelial connective tissue graft harvesting technique
Primary Outcome Measure Information:
Title
Volumetric changes during wound healing
Description
Volumetric differences of the harvested site between baseline (prior to the intervention) and every following recall will be assessed. Intraoral scans will be registered at baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention during healing. The results will be elaborated superimposing the STL files registered at very time points using Geomagic software (3d systems). The software will output a descriptive statistics: mean volumetric difference, Minimum, Maximum, Variance.
Time Frame
At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Secondary Outcome Measure Information:
Title
Patients pain perception
Description
To evaluate the postoperative pain, patients were instructed to to fill a questionnaire at every time point. The questionnaire consisted of a 100-mm Visual Analog Scale (VAS) describing the level of pain experienced on the palatal site from 0 to 10, with 10 being the worst pain ever experience, and 0 no pain.
Time Frame
At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Title
Analgesics Intake
Description
Post-operative pain was indirectly evaluated on the basis of the mean mg (milligrams) consumption of analgesics (ibuprofene).
Time Frame
At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Title
Histological Analysis
Description
Tissue samples (1 × 1 × 5 mm) harvested will be fixed in buffered 4% formaldehyde overnight. After a routine preparation for paraffin embedment including tissue immersion in a series of alcohol baths at different concentrations, the specimens will be sectioned (3 μm) with a Rotatory Microtome CUT4062 and stained with hematoxylin-eosin. The obtained sections will be examined using a Leica DMR microscope and photographed with a Leica DFC 320 digital camera. The histo-morphometrical analysis will be conducted using an image processing software with the assessment of total area of the sample (TAS), area of epithelium (AE), area of lamina propria (ALP), area of submucosa (ASM), and the average epithelium thickness (ET) measured in three different locations in each sample.
Time Frame
During surgery
Title
Immunohistoquemical Analysis of S100 protein
Description
S100 protein is characteristic of nervous tissues cells. This analysis aim to compare the subjective pain perception of other outcomes with the quantity of nervous cells found in the graft. Sections will be cut, dewaxed and rehydrated. Antibodies, along with their dilutions and sources. For antigen retrieval, heat treatments will be applied (95°C, 8 min in cell conditioning solution 1 for Glut1, calretinin and S100, and cell conditioning solution 2 for Map2) prior to the primary antibody reactions. A Tris-based buffer solution (pH 7.6 ± 0.2) was used. After UV inhibition, primary antibody reactions will be performed, in addition to counterstaining with haematoxylin. Neurone specific enolase staining will be performed. The immuno-histoquemical analysis will be conducted using an image processing software with the assessment of total area of the sample in order to count ganglia and neurons in an area of up to five high power fields in relation to it.
Time Frame
During surgery
Title
Graft dimension accuracy
Description
Graft dimensions accuracy (GDA): It will be assessed comparing GD0, the needed dimensions of the graft (x0=length, y0= height, z0= thickness), registered in advanced, with GD1, the actual dimensions of the harvested graft (x1=length, y1= height, z1= thickness).
Time Frame
During surgery
Title
post-srugical pain
Description
the following questions, both assessed at every recall. (1) Did you take any more painkillers due to the palatal pain since the procedure was completed? (2) If necessary, would you repeat the palatal harvesting procedure? (3) Did you have any unexpected post-operative incidence? Whenever the patient stopped to take analgesics the measurement of this outcome will be interrupted. Being answered by yes or no.
Time Frame
At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with at least 18 years Systemically healthy Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of < 15% Non-smokers or smokers of ≤ 10 cigarettes per day Indication of mucogingival surgery in teeth and/or implants. Exclusion Criteria: Smokers ≥ 10 cigarettes per day General contraindications for surgery Medications known to affect the gingiva or interfere with wound healing Pregnancy Benzodiazepines and/or analgesics intake Patients nos systemically healthy or uncontrolled (i.e: Diabetes, inmunosuppresed)
Facility Information:
Facility Name
Universidad Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Arroyo Furlan
Phone
648545737
Email
isabelarroyo@uic.es

12. IPD Sharing Statement

Plan to Share IPD
No

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Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg

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