NCT06114394

Complications Related to Palatal Graft Harvesting

ENROLLING BY INVITATION NA Last updated 7 August 2024

What this trial tests

NA trial testing UPV/EHU technique (Aguirre-Zorzano et al 2017) in Cicatrization in 70 participants. Enrolling by invitation.

Timeline

30 December 2023

Primary endpoint
30 December 2025

30 January 2026

Quick facts

Lead sponsor	University of the Basque Country (UPV/EHU)
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	70
Start date	30 December 2023
Primary completion	30 December 2025
Estimated completion	30 January 2026
Sites	1 location across Spain

Drugs / interventions tested

• UPV/EHU technique (Aguirre-Zorzano et al 2017)
• Single incision technique (Huerzeler & Weng 1999)

Conditions studied

• Cicatrization — all drugs for Cicatrization →

Sponsor

University of the Basque Country (UPV/EHU)

Who can join

18 and older, any sex, with Cicatrization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.