This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.
This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment. A total sample size of 30 subjects (n=30) will be evaluated at 3 centers with 4 investigators. Power analysis based on 80% power and past McGuire/ Scheyer matched-pair defect recession coverage studies, with one-sided confidence interval 0.025, indicates that in order to detect a 12% difference in root coverage with ± 15% standard deviation a patient sample of 25 should be used . Given the multi-center nature of this study and the intention to follow patients long-term, with normal attrition, 30 subjects will ensure adequate long-term follow-up and provide a "power buffer" for any outcome differences that might be seen between centers. 30 Patients with Miller Class I or II recession defects on bilateral sites will be treated randomly with coronally advanced flap (CAF) in combination with either Geistlich Fibro-Gide (GFG =Test) on one side, and Connective Tissue Graft (CTG = Control) on the contralateral side of the mouth. Follow-up visits after visit 2 surgery will be conducted at week 1,2, 4,12 and 24 and in the long term after 1,3 and 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Surgical recession root coverage with coronally advanced flap in combination with Geistlich Fibro-Gide
Surgical recession root coverage with coronally advanced flap in combination with CTG
Seven Lakes Periodontitis
Fenton, Michigan, United States
Perio Health Professionals
Houston, Texas, United States
Oral Health Specialists
Tacoma, Washington, United States
Change in percent root coverage
Change in percent root coverage compared to baseline
Time frame: 6 months post-treatment
Safety Endpoints: number and frequency of (S)AEs over all and by organ class
Assessment of (S)AEs starting at Visit 2, Surgery
Time frame: 1, 2, 4, 7, 12 and 24 weeks and year 1,3 and 5 post treatment
General Periodontal Examination (GPE)
change of GPE at various visits compared to baseline, scoring codes 0-4
Time frame: baseline (day 0) and 6 months; 1, 3, 5 years post-treatment
Assessment of Wound Healing
Judgement of soft tissue wound healing after surgery at Visits 3-6; Primary complete wound closure? yes = complete/ no = dehiscence visible
Time frame: 1, 2, 4, 12 weeks post-treatment
Assessment of Wound Healing
Judgement of soft tissue wound healing after surgery at Visits 3-6; if dehiscence visible, dehiscence size: lenght and width in mm
Time frame: 1, 2, 4, 12 weeks post-treatment
Assessment of Wound Healing
Judgement of soft tissue wound healing after surgery at Visits 3-6; presence of Swelling (yes/ no),
Time frame: 1, 2, 4, 12 weeks post-treatment
Overall Duration of Treatment Surgery
Interval from surgery start until surgery end in Hours/Minutes
Time frame: 2-6 hours at day of surgery
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Patient Reported Outcome (PRO) -Patient Diary: Discomfort
Post-Op PRO Discomfort Diary completed by Patients at home; scale 0-10, 0=no pain or discomfort at all, 10=as much as you can imagine,
Time frame: 7 days after surgery starting 1 day after surgery
Patient Reported Outcome (PRO) -Questionnaire: Esthetics
Post-Op PRO questionnaire, Esthetics and overall satisfaction, patients will be asked by a 3rd party recorder, scale 0-10, 0=not satisfied at all with estehtic appearance, 10=completely satisfied,
Time frame: 6 months, 1, 3, 5 years post-treatment
Patient Reported Outcome (PRO) -Questionnaire: for surgical preference
Post-Op PRO questionnaire, Surgival procedure Preference, patients will be asked by a 3rd party recorder, Overall which treatment did you prefer? A or B
Time frame: 1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment
Safety endpoints: Concomitant Medication
Use of Concomitant medication Review: Type of concomitant Medication used.
Time frame: 1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment