Complications Related to Palatal Graft Harvesting

NCT06114394 | Enrolling By Invitation DMC

• 1 other identifier: 2023_01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Cicatrization

Keywords

pain; connective tissue; palate

Outcome Measures

Primary Outcomes (1)

• 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?).

  After surgery up to 14 days

Secondary Outcomes (13)

• Central Sensitization Inventory severity-level score of the subject Central Sensitization inventory (CSI) (Mayer et al. 2012)

  Baseline

• Pre-surgical pain perception.

  Baseline

• Necrosis of the palate

  up to 7 days post-srugery

• Gingival recession (REC) in donor area

  Change from baseline at following surgery sixth month respectively.

• Post-surgical complications

  After surgery first seven days.

Study Arms (2)

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

EXPERIMENTAL

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

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

Single incision technique (Huerzeler & Weng 1999)

ACTIVE COMPARATOR

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

Procedure: Single incision technique (Huerzeler & Weng 1999)

Interventions

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

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

Single incision technique (Huerzeler & Weng 1999) PROCEDURE

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

Single incision technique (Huerzeler & Weng 1999)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Study Sites (1)

UPV/EHU

Leioa, Vizcaya, 48940, Spain

Location

Related Publications (7)

• 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.

  PMID: 24708394 BACKGROUND

• 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.

  PMID: 12423299 RESULT

• 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.

  PMID: 16250567 RESULT

• 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.

  PMID: 17209793 RESULT

• 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.

  PMID: 10635174 RESULT

• 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.

  PMID: 29410760 RESULT

• 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.

  PMID: 20590963 RESULT

MeSH Terms

Conditions

Cicatrix; Pain

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• ANA MARIA GARCIA DE LA FUENTE, PHD

  UPV/EHU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: October 28, 2023
• First Posted: November 2, 2023
• Study Start: December 30, 2023
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

ES (1)