this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).
The aim of this study is to clinically compare between the subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as it described by (De Sanctis \& Zucchelli 2007) with modifications in the the control group.The flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally. Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated: Recession depth (REC), change in visible plaque index, recession width (RW), width of keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog scale (VAS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
The description of this intervention has been already given before.
The description of this intervention has been already given before.
Department of Periodontics, University of Damascus Dental School
Damascus, Syrian Arab Republic, Syria
Recession depth (REC): (Change in the amount of root coverage)
from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy).
Time frame: 1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.
change in visible plaque index:
1. Score 0 - No plaque 2. Score 1 - Separate flecks of plaque at the cervical margin of the tooth 3. Score 2 - A thin continuous band of plaque at the cervical margin of the tooth 4. Score 3 - A band of plaque wider then 1mm covering less than 1/3rd of the crown of the tooth 5. Score 4 - Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth 6. Score 5 - Plaque covering 2/3rd or more of the crown of the tooth
Time frame: 1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative
Recession width (RW)
at the cemento-enamel junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Time frame: 1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.
Width of keratinized tissue (KT)
from the free gingival margin to the mucogingival junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Time frame: 1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.
Thickness of gingival tissue (GT)
with an injection needle and a silicon marker, at the mid-buccal aspect below the gingival margin.
Time frame: 1) at baseline, and 2) 3 months postoperative.
Probing depth (PD)
the distance between the gingival margin and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Time frame: 1) at baseline, 2) and 3 months postoperative.
Clinical attachment level (CAL)
distance between the CEJ and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Time frame: 1) at baseline, 2) at 3 months postoperative.
Healing index
score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence. score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration. score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Time frame: 1) at two weeks following surgery and (2) at one month following surgery.
Pain index (PI)
Using Visual Analogue scale (VAS) (2001 Crichton), Patients will be asked to select among 100 scores (0 indicating no pain at all , 50 indicating average pain, and 100 indicating very painful).
Time frame: 1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery.
Patient Perceptions
Using 100 cm Visual Analogue Scale (VAS)Patients will be asked to select among 100 scores (0 indicating very bad, 50 indicating average, and 100 indicating excellent results).
Time frame: at three months post-surgery.
Change in root sensitivity
Using a 100 cm-visual analog scale (VAS), patients' root sensitivity will be recorded with zero indicating no pain or sensitivity, 50 indicating moderate pain or sensitivity and 100 indicating worst pain or sensitivity possible.
Time frame: 1) at baseline, 2) and at 3 months postoperative.
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