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

NCT ID: NCT05828394

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2024-05-07

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).

Detailed Description

To evaluate the postoperative pain, patients were instructed to complete a 100-mm VAS and classify the level of pain experienced on the palatal site from 0 to 10, with 10 being the worst pain ever experience. Analgesics intake (AI): Post-operative pain was indirectly evaluated on the basis of the mean mg consumption of analgesics (ibuprofene). Post operative complications (PC): To evaluate the excessive bleeding., patients were instructed to complete a 100-mm VAS and classify the level of bleeding experienced on the palatal site from 0 to 10. Dimensions of the needed graft (GD0): (x0=length, y0=height, z0=thickness) it will be measured once prepared the recipient site.

Dimensions of the harvested graft (GD1): (x1=length, y1=height, z1=thickness) it will be measured with a calliper calibrated in mm just after the harvesting. Surgical time (T): time required from harvesting the graft till the suture of the donor site. Intra surgical complications (IP): perforations of the palatal flap (in the case of the SCTG) and arterial bleeding will be registered and counted as intra-surgical complications. The following parameters will be calculated:

Palatal volume changes (V changes): Volumetric differences between the intraoral scans of baseline and at every following recall will be assessed with the aim of software (Geomagic by 3d systems). Superimposing the STL files using the teeth as fixed reference points will allow to measure differences in volume changes. Graft dimensions accuracy (GDA): It will be assessed comparing GD0, the needed dimensions of the graft (x0=length, y0= height, z0= thickness) with GD1, the actual dimensions of the harvested graft (x1=length, y1= height, z1= thickness). Mean baseline thickness of the palatal soft tissues (mT0): It will be measured superimposing the cbct with the intraoral scan at baseline. The measurements will be performed using a implant planning software. Mean final thickness of the palatal soft tissues (mT1): It will be measured superimposing the cbct with the intraoral scan at 12 weeks. The measurements will be performed using a implant planning.

Conditions

Palate; Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Depithelised Free Gingival Graft, DFGG

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.

Group Type: EXPERIMENTAL

DFGG

Intervention Type: PROCEDURE

Depithelised free gingival graft harvesting technique

Subepithelial Connective Tissue Graft, SCTG

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.

Group Type: EXPERIMENTAL

SCTG

Intervention Type: PROCEDURE

Subepithelial connective tissue graft harvesting technique

Interventions

DFGG

Depithelised free gingival graft harvesting technique

Intervention Type: PROCEDURE

SCTG

Subepithelial connective tissue graft harvesting technique

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Gonzalo Blasi

Principal Investigator Gonzalo Blasi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

International University of Catalunya

Barcelona, , Spain

Countries

Spain

Other Identifiers

PER-ECL-2021-07

Identifier Type: -

Identifier Source: org_study_id