Complications Related to Palatal Graft Harvesting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-30

Study Completion Date

2026-01-30

Brief Summary

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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

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Detailed Description

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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

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Cicatrization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We will perform the experimental or control technique according to the randomization sequence.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participant: Initially, the subject will not know what technique has been received, the complete information regarding the surgical technique used, as the results obtained in his case, will be given in the last visit of the year.

Observer: Another periodoncist (R.E.), outside the intervention, would be in charge of recording the clinical parameters.

Analyst: The statistician (X.M.) does not know which treatment corresponds to each variable.

Study Groups

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UPV/EHU technique (Aguirre-Zorzano et al 2017)

Harvesting a connective tissue graft from palate by the UPV/EHU technique.

Group Type EXPERIMENTAL

UPV/EHU technique (Aguirre-Zorzano et al 2017)

Intervention Type PROCEDURE

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)

Harvesting a connective tissue graft from palate by the single incision technique

Group Type ACTIVE_COMPARATOR

Single incision technique (Huerzeler & Weng 1999)

Intervention Type PROCEDURE

The CTG is harvested with the single incsion technique described by Huerzeler \& Weng in 1999.

Interventions

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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.

Intervention Type PROCEDURE

Single incision technique (Huerzeler & Weng 1999)

The CTG is harvested with the single incsion technique described by Huerzeler \& Weng in 1999.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes