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Complications Related to Palatal Graft Harvesting

NCT06114394 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-08-07

No results posted yet for this study

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

Conditions

  • Cicatrization

Interventions

PROCEDURE

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

Single incision technique (Huerzeler & Weng 1999)

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

Sponsors & Collaborators

  • University of the Basque Country (UPV/EHU)

    lead OTHER

Principal Investigators

  • ANA MARIA GARCIA DE LA FUENTE, PHD · UPV/EHU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-30
Primary Completion
2025-12-30
Completion
2026-01-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114394 on ClinicalTrials.gov