Clinical trial NCT05828394: Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg
Official title: Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palate; Wound
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Volumetric changes during wound healing
timeFrame: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Secondary outcomes:
measure: Patients pain perception
timeFrame: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
measure: Analgesics Intake
timeFrame: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
measure: Histological Analysis
timeFrame: During surgery
measure: Immunohistoquemical Analysis of S100 protein
timeFrame: During surgery
measure: Graft dimension accuracy
timeFrame: During surgery
measure: post-srugical pain
timeFrame: At baseline and at 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the intervention
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universidad Internacional de Catalunya
state: Barcelona
city: Barcelona
country: Spain
facility: International University of Catalunya
Study officials:
References: