Palate; WoundNCT05828394
Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg
A study testing DFGG and SCTG in people with Palate; Wound, run by Universitat Internacional de Catalunya at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Palate; Wound
- What is being tested?
- DFGG and SCTG
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Feb 2023to 7 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
International University of Catalunya
Barcelona, 08172
Universidad Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
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).
Read the 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.
- Conditions
- Palate; Wound
- Being tested
- DFGG, SCTG
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFGGProcedure or surgery
Depithelised free gingival graft harvesting technique
SCTGProcedure or surgery
Subepithelial connective tissue graft harvesting technique
| Study group | Role | What they receive |
|---|---|---|
| Depithelised Free Gingival Graft, DFGG | Experimental | 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. Receives: Procedure: DFGG |
| Subepithelial Connective Tissue Graft, SCTG | Experimental | 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. Receives: Procedure: SCTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Secondary outcomes (6)
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.
Measured: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Analgesics Intake
Post-operative pain was indirectly evaluated on the basis of the mean mg (milligrams) consumption of analgesics (ibuprofene).
Measured: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
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.
Measured: During surgery
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.
Measured: During surgery
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).
Measured: During surgery
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.
Measured: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 Feb 2023
- Primary completion7 May 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palate; WoundStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Blasi, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828394
- Sponsor's protocol ID
- PER-ECL-2021-07
- Status last verified
- May 2024
- First submitted
- 16 Feb 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg
- ClinicalTrials.gov ID
- NCT05828394
- Acronym / sponsor ID
- PER-ECL-2021-07
- Conditions
- Palate; Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 25 Apr 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depithelised Free Gingival Graft, DFGG | Experimental | Procedure: DFGGThe 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. |
| Subepithelial Connective Tissue Graft, SCTG | Experimental | Procedure: SCTGThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| DFGGDepithelised free gingival graft harvesting technique | Procedure or surgery | Depithelised Free Gingival Graft, DFGG |
| SCTGSubepithelial connective tissue graft harvesting technique | Procedure or surgery | Subepithelial Connective Tissue Graft, SCTG |
Primary outcome
Volumetric changes during wound healing
Time frame: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
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.
6 secondary outcomes
Patients pain perception
Time frame: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Analgesics Intake
Time frame: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Histological Analysis
Time frame: During surgery
Immunohistoquemical Analysis of S100 protein
Time frame: During surgery
Graft dimension accuracy
Time frame: During surgery
post-srugical pain
Time frame: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DFGG and SCTG in people with Palate; Wound, run by Universitat Internacional de Catalunya at 2 sites in Spain.
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 6 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: finished, 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 2 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric changes during wound healing (time frame: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention). 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 8 May 2024.