Gingival Recession
Conditions
Brief summary
The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20 to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly assigned into two equal groups; control group; the coronally advanced flap with the subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap with amnion chorion allograft membrane (CAF+AC).
Detailed description
The participants were randomly assigned to receive coronally advanced flap (CAF) with amnion chorion membrane or CAF with subepithelial connective tissue graft using a simple randomization procedure with a 1:1 allocation ratio. A computer generated randomization list was drawn up by a faculty member who was not involved in the recruitment. Allocation concealment was achieved by sealed coded opaque envelopes that contained the treatment to be performed to the enrolled subjects based on the randomized numbers. Consequently, patients were allocated to either AC membrane (intervention) or SCTG (control) groups. The sealed envelope containing treatment assignment was opened at time of the surgery and the number was picked by another person other than the operator.
Interventions
BIOLOGICALamnion chorion allograft membrane
Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.
PROCEDUREcoronally advanced flap with the subepithelial connective tissue graft
coronally advanced flap with the placement of subepithelial connective tissue graft harvested from the palate
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects aged between 18 - 60 years old. * Subjects with facial gingival recession defects in anterior and premolar teeth classified as either class I or II defects according to Miller's classification. * Subjects able to tolerate surgical periodontal procedures. * Accepts the 6 months follow-up period.
Exclusion criteria
* Current and former smokers. * Pregnant females. * Subjects received any periodontal therapy for a minimum of 6 months prior to the study. * Subjects taking drugs known to interfere with wound healing. * Subjects with unacceptable oral hygiene with plaque index \>2. * Teeth with non-carious cervical lesions, cervical caries and malalignment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recession depth | Change in mm from baseline before surgical procedure to follow up at 6 months. | It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Width of keratinized gingiva | Change in mm from baseline before surgical procedure to follow up at 6 months. | It is measured from the mucogingival junction to the free gingival margin. |
| Probing pocket depth | Change in mm from baseline before surgical procedure to follow up at 6 months. | It is measuring the distance from the base of pocket to the gingival margin. |
| Clinical attachment level | Change in mm from baseline before surgical procedure to follow up at 6 months. | It is measuring the distance from the apical end of periodontal probe to cemento-enamel junction. |
| Recession Width | Change in mm from baseline before surgical procedure to follow up at 6 months. | It is measured as the distance from mesial and distal papillae along cemento-enamel junction. |
| root coverage esthetic score | score taken after completion of the study at 6 months | The clinical esthetic evaluation was performed without magnification to evaluate gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color |
| Patient reported outcomes | taken after completion of the study at 6 months | Patients were given certain questions regarding not regretting to perform the surgery, root hypersensitivity and aesthetic satisfaction to be answered at the 6 month follow-up for assessing their satisfaction with the whole procedure. |
| Tissue Biotype | Change in mm from baseline before surgical procedure to follow up at 6 months. | It is measured by penetrating the gingiva with the periodontal probe down to bone after giving local anesthesia to measure the thickness of gingival tissues |
Outcome results
None listed