Clinical trial NCT06114394: Complications Related to Palatal Graft Harvesting
Official title: Analysis of the Complications in Palatal Graft Harvesting With the UPV/EHU Technique vs. Single Incision Technique.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cicatrization
Keywords: pain
connective tissue
palate
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will perform the experimental or control technique according to the randomization sequence.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

* 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

Primary outcomes:
measure: Post-surgical pain perception
timeFrame: After surgery up to 14 days
Secondary outcomes:
measure: Central Sensitization Inventory severity-level score of the subject Central Sensitization inventory (CSI) (Mayer et al. 2012)
timeFrame: Baseline
measure: Pre-surgical pain perception.
timeFrame: Baseline
measure: Necrosis of the palate
timeFrame: up to 7 days post-srugery
measure: Gingival recession (REC) in donor area
timeFrame: Change from baseline at following surgery sixth month respectively.
measure: Post-surgical complications
timeFrame: After surgery first seven days.
measure: Thickness of the donor area of the palate and of the connective tissue graft
timeFrame: Surgery
measure: Length of the donor area of the palate and of the obtained CTG(mm)
timeFrame: Surgery
measure: Width of the donor area of the palate and of the obtained CTG (mm)
timeFrame: Surgery
measure: Area (mm2) of the donor area of the palate and of the obtained CTG
timeFrame: Surgery
measure: Extension of the bed recipient.
timeFrame: Baseline
measure: Full mouth bleeding index (FMBI) (Aynamo & Bay, 1975)
timeFrame: Change from baseline at following surgery sixth month respectively.
measure: Full mouth plaque index (FMPI).
timeFrame: Change from baseline at following surgery sixth month respectively.
measure: Probing depth (PD)
timeFrame: Change from baseline at following surgery sixth month respectively.
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: UPV/EHU
state: Vizcaya
Study officials:
affiliation: UPV/EHU
name: ANA MARIA GARCIA DE LA FUENTE, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Del 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.
citation: Harris 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.
citation: Griffin 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.
citation: Hurzeler 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.
citation: Aguirre-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.
citation: Zucchelli 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.