Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg

NCT05828394 | Completed

• 1 other identifier: PER-ECL-2021-07
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

A single blinded randomized clinical trial was designed to evaluate the influence of palatal harvesting technique on post-operatory patient pain perception. The participants will be selected between subjects in need of at least one mucogingival procedure involving the harvesting of a connective tissue graft and then randomly allocated in the following groups. Two harvesting techniques were chosen to be compared: de-epithelialized free gingival graft (DFGG) and subepithelial connective tissue graft (SCTG).

Conditions

Palate; Wound

Outcome Measures

Primary Outcomes (1)

• Volumetric changes during wound healing

  Volumetric differences of the harvested site between baseline (prior to the intervention) and every following recall will be assessed. Intraoral scans will be registered at baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention during healing. The results will be elaborated superimposing the STL files registered at very time points using Geomagic software (3d systems). The software will output a descriptive statistics: mean volumetric difference, Minimum, Maximum, Variance.

  At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention

Secondary Outcomes (6)

• Patients pain perception

  At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention

• Analgesics Intake

  At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention

• Histological Analysis

  During surgery

• Immunohistoquemical Analysis of S100 protein

  During surgery

• Graft dimension accuracy

  During surgery

Study Arms (2)

Depithelised Free Gingival Graft, DFGG

EXPERIMENTAL

The group assignment was communicated through a sealed envelope that was opened just prior to the surgery. The subjects will undergo to a harvesting procedure of a palatal graft using DFGG technique described as following: two horizontal and two vertical incisions will be traced with a 15C blade to delimit the area to be grafted. Along the coronal horizontal incision, the blade will be oriented almost perpendicular to the bone plate and once an adequate soft tissue thickness was obtained, it will be rotated in order to be almost parallel to the superficial surface. The thickness of the graft will be maintained uniform while proceeding apically with the blade. Once the graft is separated, the adipose and glandular tissue as well as the epithelium will be removed extra orally with a new blade. Finally the palate will be sutured with 5-0 monofilament suture and collagen sponges. In this group the palate is suppose to have a secondary intention healing.

Procedure: DFGG

Subepithelial Connective Tissue Graft, SCTG

EXPERIMENTAL

The group assignment was communicated through a sealed envelope that was opened just prior to the surgery. The subjects will undergo to a harvesting procedure of a palatal graft using SCTG technique described as following: one deep horizontal incision parallel to the gingival margin will be traced at 1.5 mm apical to the gingival margin of the adjacent teeth, according to the palatal pocket depth of the teeth. A deeper incision parallel and deeper to the initial one will be performed. The primary flap will be elevated split-thickness. The horizontal incision will be made almost perpendicular to the underlying bone. Once an adequate soft tissue thickness is obtained, the blade will be rotated in order to be almost parallel to the external surface. The thickness of the graft will be maintained uniform. Finally the palate will be sutured with 5-0 monofilament suture and collagen sponges.In this group the palate is suppose to have a primary intention healing.

Procedure: SCTG

Interventions

DFGG PROCEDURE

Depithelised free gingival graft harvesting technique

Depithelised Free Gingival Graft, DFGG

SCTG PROCEDURE

Subepithelial connective tissue graft harvesting technique

Subepithelial Connective Tissue Graft, SCTG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least 18 years
• Systemically healthy
• Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy
• Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of \< 15%
• Non-smokers or smokers of ≤ 10 cigarettes per day
• Indication of mucogingival surgery in teeth and/or implants.

You may not qualify if:

• Smokers ≥ 10 cigarettes per day
• General contraindications for surgery
• Medications known to affect the gingiva or interfere with wound healing
• Pregnancy
• Benzodiazepines and/or analgesics intake
• Patients nos systemically healthy or uncontrolled (i.e: Diabetes, inmunosuppresed)

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (2)

Universidad Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

International University of Catalunya

Barcelona, 08172, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Gonzalo Blasi

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: April 25, 2023
• Study Start: February 15, 2023
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)