CicatrizationNCT06114394
Complications Related to Palatal Graft Harvesting
A study testing UPV/EHU technique (Aguirre-Zorzano et al 2017) and Single incision technique (Huerzeler & Weng 1999) in people with Cicatrization, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial summary
Soft tissue defects can be a problem, especially in patients with high smile lines; in these clinical scenarios, the treatment with periodontal plastic surgery in combination with the use of a connective tissue graft (CTG) is considered the gold-standard procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cicatrization
- What is being tested?
- UPV/EHU technique (Aguirre-Zorzano et al 2017) and Single incision technique (Huerzeler & Weng 1999)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 30 Dec 2023to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of the UPV/EHU university dental clinic who required a connective graft of the palate in their treatment.
- Patients ≥ 18 years-old
- Absence of active periodontal disease ( healthy periodontal patients or periodontal patients who had received active periodontal treatment, and now they are included in a tailored supportive periodontal program)
- Full-mouth plaque index (FMPI) (O'Leary y cols. 1972) and full-mouth bleeding index (FMBI) (Ainamo y Bay, 1975) ≤ 25%
Who cannot join
- Smokers of ≥ 10 cigarettes/day
- Systemic conditions that contraindicated surgery
- The use of analgesic and/or anti-inflammatory drugs in the last 72 h
- The use of opioid drugs, anticonvulsants and/or antidepressants, except selective serotonin inhibitors, i.e., those drugs that act by reducing the painful experience
- Pregnancy or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Complications in Palatal Graft Harvesting With the UPV/EHU Technique vs. Single Incision Technique.
Soft tissue defects can be a problem, especially in patients with high smile lines; in these clinical scenarios, the treatment with periodontal plastic surgery in combination with the use of a connective tissue graft (CTG) is considered the gold-standard procedure.
Single incision technique (Huerzeler \& Weng, 1999) is one of the suggested procedures to harvest the CTG from palate. The UPV/EHU technique (Aguirre-Zorzano et al, 2017) showed less inflammation and post-surgical complications than trap-door technique, but also other technique should to be analysed.
Read more
However, there is still no consensus about which is the best technique to obtain this kind of graft. Therefore, clinicians should justify their choice based on the tissue's quality obtained and the patient's well-being, producing the least number of complications, such as inflammation, post-surgical pain, or recession in the donor area.
HYPOTHESIS:
Does the technique of obtaining an CTG of the palate using the "UPV/EHU technique" (Aguirre-Zorzano et al., 2017) result in a lower number of complications versus the "single incision technique" (Huerzeler \& Weng, 1999)?
OBJECTIVES The main objective is to assess whether the complications occurring with the harvesting of the CTG using the "UPV/EHU technique" (Aguirre-Zorzano et al., 2017) are lower than with the "single incision technique"(Huerzeler \& Weng, 1999), knowing the patient's perception of pain.
The secondary objectives are: a) necrosis of the palate, b) possible resulting recession in the donor area, and c) characteristics of the graft obtained
Read the detailed description
Type of Study: randomized clinical trial
Two different treatments (UPV/EHU technique (test) (Aguirre-Zorzano et al. 2017) vs. Single Incision technique (control) (Huerzeler \& Weng, 1999)) will be compared. These techniques are usually used to harvest a CTG from the palate.
Main outcome: complications in the donor area.
Follow-up: 6 months.
UNIT OF ANALYSIS: The patient of the Master's Degree in Periodontology and Osseointegration from the University of the Basque Country (UPV/EHU), requires treatment with a CTG harvested from the palate.
SAMPLE SIZE CALCULATION: Using the visual analog pain scale (VAS pain) as the primary response variable, it is estimated that, to find a difference of 1 between test and control, with an SD= 1.26 (Wessel \& Tatakis 2008), an alpha risk of 5% and a power of 85%, we would need 29 patients for each treatment group (Domenech and Granero 2010). In addition, taking into account possible dropouts, we would increase the number of patients by 20%, finally recruiting 35 patients per group.
Statistical analysis:
A descriptive study of the sample will be performed, based on moments (mean, standard deviation) if the parameters of normality are met or on ordinations (median and interquartile range), in case the parameters of normality are not met.
Subsequently, analytical statistics will be performed, and in addition, the intensity and duration of post-surgical pain after each surgical technique adjusted for possible confounding factors (clinical level of central sensitization, presence of pre-surgical pain, presence of post-surgical complications, use of added analgesic treatment) will be assessed using logistic regression.
- Conditions
- Cicatrization
- Being tested
- UPV/EHU technique (Aguirre-Zorzano et al 2017), Single incision technique (Huerzeler & Weng 1999)
- Keywords
- pain, connective tissue, palate
- Medical subject headings
- Cicatrix, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPV/EHU technique (Aguirre-Zorzano et al 2017)Procedure or surgery
The "UPV/EHU technique" (Aguirre-Zorzano et al., 2017) begins with the elevation of the full thickness flap (FTF) in the palate and an intrasulcular incision performed with a number 12 blade, preserving the papillae in the interproximal spaces. Then, the FTF is dissected with a 15c blade, holding the flap with tissue forceps, leaving the epithelium and a thin layer of the connective tissue in the flap, so that the underlying connective tissue can be harvested. After that the flap is sutured.
Single incision technique (Huerzeler & Weng 1999)Procedure or surgery
The CTG is harvested with the single incsion technique described by Huerzeler \& Weng in 1999.
| Study group | Role | What they receive |
|---|---|---|
| UPV/EHU technique (Aguirre-Zorzano et al 2017) | Experimental | Harvesting a connective tissue graft from palate by the UPV/EHU technique. Receives: Procedure: UPV/EHU technique (Aguirre-Zorzano et al 2017) |
| Single incision technique (Huerzeler & Weng 1999) | Active comparator | Harvesting a connective tissue graft from palate by the single incision technique Receives: Procedure: Single incision technique (Huerzeler & Weng 1999) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical pain perception
The subject will we instructed to collect their perception of post-surgical pain in the VAS based on the UPV/EHU Pain diary (Fernandez-Jimenez et al, 2021). Specifically the subject will record: Its intensity (0-100mm), its duration (minutes or hours) and if any analgesic treatment has been necessary (No o Yes: Which?).
Measured: After surgery up to 14 days
Secondary outcomes (13)
Central Sensitization Inventory severity-level score of the subject Central Sensitization inventory (CSI) (Mayer et al. 2012)
Central Sensitization inventory (CSI) (Mayer et al. 2012) will be done, in which each subject will be asked on the frequency in which he perceives 25 symptoms and will be given a score of 0-4 finally establishing a clinical level in a range of 0-100 points (Subclinical: 0-29; Medium: 30-39; Moderate: 40-49 ; Severe: 50-59; Extreme: 60-100).
Measured: Baseline
Pre-surgical pain perception.
In the VAS based on the UPV/EHU Pain Diary (Fernandez-Jimenez et al 2021) the examiner will record if the subject has had regional head and neck pain in the last month and if there is any pain in the immediate preoperative, if it is affirmative the intensity will be noted
Measured: Baseline
Necrosis of the palate
After using 2 CP-11 periodontal probes by placing them perpendicularly, thus obtaining a measured in the X-axis and another in the Y-axis and multiplying both results, the donor area in mm2 will be obtained. From that point on, it will be possible to determine what degree of necrosis has occurred in the donor area by taking the following values as a reference (Aguirre-Zorzano et al. 2017):
Value 0: total absence of necrosis. Value 1 : ≦30% of the donor area. Value 2: ≧ 30% of the donor area.
Measured: up to 7 days post-srugery
Gingival recession (REC) in donor area
Distance in mm from the amelocementaria line the gingival margin, measured at the vestibular midpoint. It will be registered in all the teeth present in the donor area at the beginning, and, during the follow-up only in the recessions to be treated
Measured: Change from baseline at following surgery sixth month respectively.
Post-surgical complications
The presence or not, as the description, of the post-surgical complications (PSC) that may appear will be collected.
Measured: After surgery first seven days.
Thickness of the donor area of the palate and of the connective tissue graft
measured using 2 CP-11 periodontal probes and placing them perpendicularly, thus creating a measurement in the X axis and another in the Y axis, in order to obtain the area in mm2 of the graft obtained by multiplying both measurements, and placing a file with a rubber stopper in the central area of the graft to measure its thickness.
Measured: Surgery
Length of the donor area of the palate and of the obtained CTG(mm)
by positioning a CP-11 periodontal probe parallel to the donor area on the palate, as well as on the connective tissue graft obtained
Measured: Surgery
Width of the donor area of the palate and of the obtained CTG (mm)
by positioning a CP-11 periodontal probe perpendicular to the donor area on the palate, as well as on the obtained connective tissue graft.
Measured: Surgery
Area (mm2) of the donor area of the palate and of the obtained CTG
: measurement obtained by multiplying the variables length and width of the donor area, as well as of the obtained CTG.
Measured: Surgery
Extension of the bed recipient.
The number of teeth or implants will be registered in the bed receipt.
Measured: Baseline
Full mouth bleeding index (FMBI) (Aynamo & Bay, 1975)
After a periodontal probing of all teeth, the presence (yes or no) of bleeding is recorded dichotomously at 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and the percentage of sites that bleed from the total of probed sites is calculated (Ainamo and Bay 1975)
Measured: Change from baseline at following surgery sixth month respectively.
Full mouth plaque index (FMPI).
A plaque developer is used and the presence (yes or no) of plaque is recorded dichotomously at 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and the percentage of sites with plaque of the total probed sites is calculated (O'Leary et al 1972).
Measured: Change from baseline at following surgery sixth month respectively.
Probing depth (PD)
Distance in millimeters from the gingival margin to the bottom of the periodontal pocket. It will be recorded at the beginning in all teeth present (except wisdow teeth) in 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and, during follow-up, only in the recessions to be treated at the vestibular mid-point.
Measured: Change from baseline at following surgery sixth month respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start30 Dec 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CicatrizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will perform the experimental or control technique according to the randomization sequence.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María García de la Fuente, University of the Basque Country (UPV/EHU)
- Investigators
- ANA MARIA GARCIA DE LA FUENTE, PHD, Study director, UPV/EHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114394
- Sponsor's protocol ID
- 2023_01
- Status last verified
- Aug 2024
- First submitted
- 28 Oct 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zucchelli G, Mounssif I, Mazzotti C, Montebugnoli L, Sangiorgi M, Mele M, Stefanini M. Does the dimension of the graft influence patient morbidity and root coverage outcomes? A randomized controlled clinical trial. J Clin Periodontol. 2014 Jul;41(7):708-16. doi: 10.1111/jcpe.12256. Epub 2014 May 8.
PubMed 24708394Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x.
PubMed 12423299Harris RJ, Miller R, Miller LH, Harris C. Complications with surgical procedures utilizing connective tissue grafts: a follow-up of 500 consecutively treated cases. Int J Periodontics Restorative Dent. 2005 Oct;25(5):449-59.
PubMed 16250567Griffin TJ, Cheung WS, Zavras AI, Damoulis PD. Postoperative complications following gingival augmentation procedures. J Periodontol. 2006 Dec;77(12):2070-9. doi: 10.1902/jop.2006.050296.
PubMed 17209793Hurzeler MB, Weng D. A single-incision technique to harvest subepithelial connective tissue grafts from the palate. Int J Periodontics Restorative Dent. 1999 Jun;19(3):279-87.
PubMed 10635174Aguirre-Zorzano LA, Garcia-De La Fuente AM, Estefania-Fresco R, Marichalar-Mendia X. Complications of harvesting a connective tissue graft from the palate. A retrospective study and description of a new technique. J Clin Exp Dent. 2017 Dec 1;9(12):e1439-e1445. doi: 10.4317/jced.54337. eCollection 2017 Dec.
PubMed 29410760Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
PubMed 20590963
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Complications in Palatal Graft Harvesting With the UPV/EHU Technique vs. Single Incision Technique.
- ClinicalTrials.gov ID
- NCT06114394
- Acronym / sponsor ID
- 2023_01
- Conditions
- Cicatrization
- Keywords
- pain, connective tissue, palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 2 Nov 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.
Soft tissue defects can be a problem, especially in patients with high smile lines; in these clinical scenarios, the treatment with periodontal plastic surgery in combination with the use of a connective tissue graft (CTG) is considered the gold-standard procedure.
Single incision technique (Huerzeler \& Weng, 1999) is one of the suggested procedures to harvest the CTG from palate. The UPV/EHU technique (Aguirre-Zorzano et al, 2017) showed less inflammation and post-surgical complications than trap-door technique, but also other technique should to be analysed.
However, there is still no consensus about which is the best technique to obtain this kind of graft. Therefore, clinicians should justify their choice based on the tissue's quality obtained and the patient's well-being, producing the least number of complications, such as inflammation, post-surgical pain, or recession in the donor area.
HYPOTHESIS:
Does the technique of obtaining an CTG of the palate using the "UPV/EHU technique" (Aguirre-Zorzano et al., 2017) result in a lower number of complications versus the "single incision technique" (Huerzeler \& Weng, 1999)?
OBJECTIVES The main objective is to assess whether the complications occurring with the harvesting of the CTG using the "UPV/EHU technique" (Aguirre-Zorzano et al., 2017) are lower than with the "single incision technique"(Huerzeler \& Weng, 1999), knowing the patient's perception of pain.
The secondary objectives are: a) necrosis of the palate, b) possible resulting recession in the donor area, and c) characteristics of the graft obtained
Detailed description
Type of Study: randomized clinical trial
Two different treatments (UPV/EHU technique (test) (Aguirre-Zorzano et al. 2017) vs. Single Incision technique (control) (Huerzeler \& Weng, 1999)) will be compared. These techniques are usually used to harvest a CTG from the palate.
Main outcome: complications in the donor area.
Follow-up: 6 months.
UNIT OF ANALYSIS: The patient of the Master's Degree in Periodontology and Osseointegration from the University of the Basque Country (UPV/EHU), requires treatment with a CTG harvested from the palate.
SAMPLE SIZE CALCULATION: Using the visual analog pain scale (VAS pain) as the primary response variable, it is estimated that, to find a difference of 1 between test and control, with an SD= 1.26 (Wessel \& Tatakis 2008), an alpha risk of 5% and a power of 85%, we would need 29 patients for each treatment group (Domenech and Granero 2010). In addition, taking into account possible dropouts, we would increase the number of patients by 20%, finally recruiting 35 patients per group.
Statistical analysis:
A descriptive study of the sample will be performed, based on moments (mean, standard deviation) if the parameters of normality are met or on ordinations (median and interquartile range), in case the parameters of normality are not met.
Subsequently, analytical statistics will be performed, and in addition, the intensity and duration of post-surgical pain after each surgical technique adjusted for possible confounding factors (clinical level of central sensitization, presence of pre-surgical pain, presence of post-surgical complications, use of added analgesic treatment) will be assessed using logistic regression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We will perform the experimental or control technique according to the randomization sequence.
| Arm | Type | Receives |
|---|---|---|
| UPV/EHU technique (Aguirre-Zorzano et al 2017) | Experimental | Procedure: UPV/EHU technique (Aguirre-Zorzano et al 2017)Harvesting a connective tissue graft from palate by the UPV/EHU technique. |
| Single incision technique (Huerzeler & Weng 1999) | Active comparator | Procedure: Single incision technique (Huerzeler & Weng 1999)Harvesting a connective tissue graft from palate by the single incision technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of the UPV/EHU university dental clinic who required a connective graft of the palate in their treatment.
- Patients ≥ 18 years-old
- Absence of active periodontal disease ( healthy periodontal patients or periodontal patients who had received active periodontal treatment, and now they are included in a tailored supportive periodontal program)
- Full-mouth plaque index (FMPI) (O'Leary y cols. 1972) and full-mouth bleeding index (FMBI) (Ainamo y Bay, 1975) ≤ 25%
Key exclusion criteria (5 listed)
- Smokers of ≥ 10 cigarettes/day
- Systemic conditions that contraindicated surgery
- The use of analgesic and/or anti-inflammatory drugs in the last 72 h
- The use of opioid drugs, anticonvulsants and/or antidepressants, except selective serotonin inhibitors, i.e., those drugs that act by reducing the painful experience
- Pregnancy or nursing women
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 |
|---|---|---|
| UPV/EHU technique (Aguirre-Zorzano et al 2017)The "UPV/EHU technique" (Aguirre-Zorzano et al., 2017) begins with the elevation of the full thickness flap (FTF) in the palate and an intrasulcular incision performed with a number 12 blade, preserving the papillae in the interproximal spaces. Then, the FTF is dissected with a 15c blade, holding the flap with tissue forceps, leaving the epithelium and a thin layer of the connective tissue in the flap, so that the underlying connective tissue can be harvested. After that the flap is sutured. | Procedure or surgery | UPV/EHU technique (Aguirre-Zorzano et al 2017) |
| Single incision technique (Huerzeler & Weng 1999)The CTG is harvested with the single incsion technique described by Huerzeler \& Weng in 1999. | Procedure or surgery | Single incision technique (Huerzeler & Weng 1999) |
Primary outcome
Post-surgical pain perception
Time frame: After surgery up to 14 days
The subject will we instructed to collect their perception of post-surgical pain in the VAS based on the UPV/EHU Pain diary (Fernandez-Jimenez et al, 2021). Specifically the subject will record: Its intensity (0-100mm), its duration (minutes or hours) and if any analgesic treatment has been necessary (No o Yes: Which?).
13 secondary outcomes
Central Sensitization Inventory severity-level score of the subject Central Sensitization inventory (CSI) (Mayer et al. 2012)
Time frame: Baseline
Pre-surgical pain perception.
Time frame: Baseline
Necrosis of the palate
Time frame: up to 7 days post-srugery
Gingival recession (REC) in donor area
Time frame: Change from baseline at following surgery sixth month respectively.
Post-surgical complications
Time frame: After surgery first seven days.
Thickness of the donor area of the palate and of the connective tissue graft
Time frame: Surgery
Length of the donor area of the palate and of the obtained CTG(mm)
Time frame: Surgery
Width of the donor area of the palate and of the obtained CTG (mm)
Time frame: Surgery
Area (mm2) of the donor area of the palate and of the obtained CTG
Time frame: Surgery
Extension of the bed recipient.
Time frame: Baseline
Full mouth bleeding index (FMBI) (Aynamo & Bay, 1975)
Time frame: Change from baseline at following surgery sixth month respectively.
Full mouth plaque index (FMPI).
Time frame: Change from baseline at following surgery sixth month respectively.
Probing depth (PD)
Time frame: Change from baseline at following surgery sixth month respectively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 24708394Zucchelli G, Mounssif I, Mazzotti C, Montebugnoli L, Sangiorgi M, Mele M, Stefanini M. Does the dimension of the graft influence patient morbidity and root coverage outcomes? A randomized controlled clinical trial. J Clin Periodontol. 2014 Jul;41(7):708-16. doi: 10.1111/jcpe.12256. Epub 2014 May 8.
- Results publication: PubMed 12423299Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x.
- Results publication: PubMed 16250567Harris RJ, Miller R, Miller LH, Harris C. Complications with surgical procedures utilizing connective tissue grafts: a follow-up of 500 consecutively treated cases. Int J Periodontics Restorative Dent. 2005 Oct;25(5):449-59.
- Results publication: PubMed 17209793Griffin TJ, Cheung WS, Zavras AI, Damoulis PD. Postoperative complications following gingival augmentation procedures. J Periodontol. 2006 Dec;77(12):2070-9. doi: 10.1902/jop.2006.050296.
- Results publication: PubMed 10635174Hurzeler MB, Weng D. A single-incision technique to harvest subepithelial connective tissue grafts from the palate. Int J Periodontics Restorative Dent. 1999 Jun;19(3):279-87.
- Results publication: PubMed 29410760Aguirre-Zorzano LA, Garcia-De La Fuente AM, Estefania-Fresco R, Marichalar-Mendia X. Complications of harvesting a connective tissue graft from the palate. A retrospective study and description of a new technique. J Clin Exp Dent. 2017 Dec 1;9(12):e1439-e1445. doi: 10.4317/jced.54337. eCollection 2017 Dec.
- Results publication: PubMed 20590963Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
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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.
ANA MARIA GARCIA DE LA FUENTE, PHD study director
UPV/EHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPV/EHU technique (Aguirre-Zorzano et al 2017) and Single incision technique (Huerzeler & Weng 1999) in people with Cicatrization, run by University of the Basque Country (UPV/EHU) at 1 site 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 4 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 7 Aug 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 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?
Results are not available in the source record.
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?
Post-surgical pain perception (time frame: After surgery up to 14 days). 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 NCT06114394, which also lists 7 linked publications.
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 7 Aug 2024.