Clinical trial NCT04028037: Effectiveness of Full-thickness Palatal Graft Technique (FTPGT) in Obtaining Complete Root Coverage
Official title: Clinical Comparison of Full-thickness Palatal Graft Technique (FTPGT) vs Coronally Advanced Flap With Subepithelial Connective Tissue Graft (CAF+SCTG)in Obtaining Complete Root Coverage: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized controlled clinical trial we will compare the clinical outcome of Full thickness palatal graft technique (FTPGT) to coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) in the treatment of RT1 (Cairo et al. classification) recessions.

Forty patients, presenting at least one RT1 recession, will be treated with bilaminar procedures . 20 participants will receive FTPGT approach (test group) and 20 patients will undergo CAF+SCTG (control group). Complete root coverage (CRC) will be assumed as the main outcome at 12 months after treatment. Gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT,) thickness of keratinized tissue (GT) will be assessed at baseline and 12 months after treatment. Patient-reported outcome measures (PROMs) will be reported: namely, the number of painkiller tablets taken during the first week, the degree of general discomfort (D) experienced assessed on a VAS scale (0-10), the extent of changes in their eating habits (CFH), dentin hypersensitivity (DH), patient-reported aesthetic satisfaction (PRES) quantified on a VAS scale (0-10) and overall treatment satisfaction (OTS).

Detailed description: This study will be a prospective, randomized and controlled clinical trial designed to compare two modalities of treatment of RT1 recessions: FTPG versus CAF+SCTG. From each patient study one RT1 recession will be included. Clinical parameters will be evaluated at baseline and 12 months after treatment.

40 patients seeking treatment at the Unit of Periodontology of the University of Chieti, Pescara, Italy, and affected by RT1 recessions will be selected for the study.

All 40 patient will undergo a professional supra-gingival scaling by ultrasonic instruments. To each patient motivational oral home care instructions in order to acquire correct and pressure-less brushing technique and a-traumatic use of dental floss and/or inter-dental brush will be given. In addition electric toothbrush use with controlled pressure with extra-soft head will be suggested and instructions about it will be conferred. Only the achievement of supra-gingival plaque control through a-traumatic oral hygiene procedures will permit the access of the surgical step.

Custom made computer-generated table provides the randomly allocation of experimental unit in the two groups.

The post-surgical care will be founded for all patients on 2 g/day amoxicillin plus clavulanic acid for 6 days, oral ketoprofen for pain-control if needed . Two weeks after surgery suture will be removed. Plaque control of grafted area will be performed for 3 weeks after surgery through a double rinse in a day with 0.12% chlorhexidine digluconate solution. Furthermore, the patients will use a 1% chlorhexidine gel twice daily. Patients underwent weekly supragingival hygiene and motivational reinforcement for 6 weeks. Cautious brushing by a soft toothbrush and interdental brushing will be recommended only 2 weeks after sutures removal.

All measurements will be performed by a single experienced operator. Complete root coverage (CRC) will be assumed as the main outcome at 12 months after treatment. Gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT,) thickness of keratinized tissue (GT) will be assessed at baseline and 12 months after treatment.

PROMs will also be evaluated. That is, patients will be asked to write down the number of painkiller tablets (400 mg of ibuprofen) taken during the study the first week.

The degree of general discomfort (D) experienced will be assessed on a VAS scale (0-10), and the extent of changes in their eating habits (CFH) caused by the palate will be indicated wound. Dentin hypersensitivity (DH) will be evaluated at T0 and T1 according to a scale from 0 to 3 (0" reaction to the air stimulus; "1" reaction without requiring its termination; "2" reaction and request to stop it; "3" painful stimulus complaint).

Patient-reported aesthetic satisfaction (PRES) at T1 will also be quantified on a VAS scale (0-10). Overall treatment satisfaction (OTS) at T1 will be assessed by asking each patient if they would undergo surgery again (yes/no).

Eligibility criteria: Inclusion Criteria:

* systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation
* never smokers/former smokers \>=10years
* a full-mouth plaque score (FMPS)and a full-mouth bleeding score (FMBS) lower than 15%
* no periodontal surgery on the experimental sites
* \>= 20 teeth without mobility
* no presence of cervical carious lesions or periapical lesions at experimental sites
* at leat one RT1 buccal gingival recession

Exclusion Criteria:

* systemic diseases
* coagulation disorders
* medications affecting periodontal status in the previous 6 months
* pregnancy or lactation
* Smokers

Primary outcomes:
measure: Percentage (%) of Complete Root Coverage (CRC)
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Attachment Level (CAL)
timeFrame: 12 months
measure: Pocket Depth (PD)
timeFrame: 12 months
measure: Gingival Thickness (GT)
timeFrame: 12 months
measure: Keratinized Tissue width (KT)
timeFrame: 12 months
measure: Number of painkiller tables
timeFrame: First week after surgery
measure: Overall Discomfort (D)
timeFrame: 2 weeks after surgery
measure: Feeding Habits Changes (CFH)
timeFrame: 2 weeks after surgery
measure: Dentine hypersensitivity (DH)
timeFrame: 12 months
measure: Patient-Reported Esthetic Satisfaction (PRES)
timeFrame: 12 months
measure: Overall Treatment Satisfaction (OTS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: G. d'Annunzio University
state: CH
Study officials:
affiliation: università G. D'annunzio Chieti-Pescara
name: michele paolantonio
role: PRINCIPAL_INVESTIGATOR
References: