Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04813302 |
| Other study ID # |
PER-ECL-2019-04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2019 |
| Est. completion date |
March 15, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Universitat Internacional de Catalunya |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction:
Gingival recession is a lesion characterized by the loss of attachment of root surface of the
tooth, resulting in an apical migration of the gingival margin that occasionally generates
aesthetic problems, hypersensitivity and difficulty in maintaining proper hygiene.
Several anatomical factors have been associated both with the incidence and progression of
gingival recession and with the prognosis of the surgical treatments proposed for its
correction. These factors include the absence of keratinized tissue, the gingival phenotype,
root prominence and shallow vesrtibular depth.
Objectives:
The objective of the study is to evaluate, through a series of prospective cases, the
influence of each of the anatomical factors on the success of root coverage.
Methods:
20 patients with gingival recession defects will be treated with CAF+CTG using various
autogenous gingival graft. Three-dimensional analysis of superimposed preoperative and
postoperative images will be performed. Linear and surface root coverage will be calculated
and correlated to various anatomical parameters such as vestibular depth and root prominence.
A multilevel statistical analysis will be conducted, adjusting for the correlation among
multiple observations.
Description:
- Pre-surgical treatment: Initial periodontal therapy will be performed 1 month prior to
surgery. Patients will receive a pre-surgical prophylaxis, oral hygiene instructions and
elimination of toothbrushing traumatic technique, if needed. They will be taught to use a
toothbrush of medium hardness applying Roll brushing technique.
- Surgical treatment: In brief description, CAF+CTG treatment will be performed by starting
with two vertical releasing incisions lateral to the teeth to be treated and split-full-split
thickness flap will be raised beyond the MGJ. The periosteum will be cut, and a blunt
dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension
so that the mucosal flap can be passively positioned above the level of CEJ on the tooth. The
papillae adjacent to the involved teeth will be de-epithelialized and the exposed root
surfaces will be treated with pre-conditioning EDTA (Straumann PrefGel®) for 2 minutes. CTG
of 1mm in thickness will be harvested from the posterior palate by means of disepithelization
of a free gingival graft (22), cut to the exact size of the defect, and placed over the
dehisced defect, sutured to the interdental papillae (7-0 Polyglactin 910, Vycril, Ethicon,
Johnson and Johnson, New Brunswick, NJ, USA) and subsequently covered with CAF. Sling sutures
will be placed to stabilize the flap in a coronal position about 1-2 mm above the CEJ (6-0
Polypropylene, Prolene, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA), followed by
interrupted sutures to close the releasing incisions.
Patients will be instructed to avoid any mechanical trauma or tooth brushing in the surgical
sites for 2 weeks. Analgesic medication (ibuprofen) will be prescribed as required and
patients will be instructed to rinse with Chlorhexidine three times per day for 2 weeks.
Sutures will be removed after 14 days. Two weeks after surgery, patients will resume
mechanical tooth cleaning with a soft toothbrush. Patients will be recalled at 1, 3 and 6
months for professional oral hygiene procedures.
- Post-surgical instructions and infection control: Patients will be instructed to avoid any
mechanical trauma or tooth brushing in the surgical sites for 2 weeks. Analgesic medication
(ibuprofen) will be prescribed as required and patients will be instructed to rinse with
Chlorhexidine 0.12% two times per day for 2 weeks. Sutures will be removed after 14 days. Two
weeks after surgery, patients will resume mechanical tooth cleaning with a soft toothbrush.
Patients will be recalled at 1, 3 and 6 months for professional oral hygiene procedures.
- Data collection: A guidebook will be prepared to systematize the procedures for sample and
data collection. The data will be later transferred to a computerized database (Epidata®,
Odense, Denmark, Europe).
A) Sociodemographic data An interview will be conducted during the pre-surgical visit to
obtain information regar- ding age, sex, medical history, use of medication, exposure to
tobacco, pregnancy and previous periodontal surgeries.
B) Clinical measurements Probing depth (PD) and keratinized tissue width (KTW) will be
measured using a periodontal probe (PCP UNC 15, Hu-Friedy, Chicago, IL, USA). KTW will be
measured at the most apical point in the GM to the mucogingival junction at the mid-buccal
site to the nearest millimeter. KTT will be measured 1.5mm and 3mm apical to the GM using an
injection needle, perpendicular to the tissues surface and a silicon stop over the gingival
surface and fixed with a cyanoacrylic adhesive (23). Clinical attachment level will be
calculated as REC + PD.
C) Digital measurements All patients will be scanned and their models will be digitalized
with an optical 3D measurement system (3Shape, Erlangen, Germany) creating surface
tessellation language (STL) files while a bilateral retractor is placed in the mouth and
teeth are held lightly in occlusion. The acquired data will be transferred into a digital
imaging software (3Shape Trios®, Erlangen, Germany) in which patient name will be substituted
for a random ID number in order to anonymize the data. Baseline and corresponding follow-up
scans of each clinical case will be then virtually superimposed and matched into one common
coordinate system (Geomagic, 3D Systems, Research Triangle Park, NC, USA) using the tool
Control X. By using the buccal surfaces of the concerned teeth as reference points for the
superpositioning of the different time points (pre-operative and post-operative), this
approach will allow for precise evaluation of dimensional soft tissue alterations over time
by a blinded examiner. Vestibular depth will be measured from the GM to the point of greatest
concavity of the mucobuccal fold.
The digital linear and volumetric measurements and assessment will be performed by a single,
calibrated examiner for the surgical. The examiner will be trained on 15 casts with gingival
recessions who will not be included in this study. This examination will be repeated 24 h
later; differences of ≤0.5 mm in at least 90% of the cases will be considered to be
acceptable.
The following measurements will be taken:
All clinical measurements and volumetric evaluations of the soft will be performed at
baseline, 3 months and at 6 months after surgery.
