An interventional study of UPV/EHU technique (Aguirre-Zorzano et al 2017) and Single incision technique (Huerzeler & Weng 1999) in Cicatrization, sponsored by University of the Basque Country (UPV/EHU). Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by University of the Basque Country (UPV/EHU) · Not applicable, Interventional, and Treatment
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
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.
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
This study's planned enrollment of 70 is above the median of 40 across 512 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →University of the Basque Country (UPV/EHU) is the lead sponsor of 37 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Harvesting a connective tissue graft from palate by the UPV/EHU technique.
Procedure: UPV/EHU technique (Aguirre-Zorzano et al 2017)
Harvesting a connective tissue graft from palate by the single incision technique
Procedure: Single incision technique (Huerzeler & Weng 1999)
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.
The CTG is harvested with the single incsion technique described by Huerzeler \& Weng in 1999.
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?).
Time frame: After surgery up to 14 days
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).
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Surgery
Extension of the bed recipient.
The number of teeth or implants will be registered in the bed receipt.
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: Change from baseline at following surgery sixth month respectively.
Started Dec 2023 (actual). Primary completion is estimated for Dec 2025, 24 months after the start.
Of 173 non-industry interventional studies with no phase under Cicatrix, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's planned 24 months is above that.
Counting every sponsor, half of 206 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
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University of the Basque Country (UPV/EHU)