Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04028037 |
| Other study ID # |
uchieti2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2015 |
| Est. completion date |
October 2018 |
Study information
| Verified date |
November 2023 |
| Source |
G. d'Annunzio University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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).
