Faculty of Dentistry- Ain Shams University
Cairo, Egypt
NCT Number: NCT07162207
The goal of this clinical trial is evaluation of the change in depth and width of gingival recession in terms of gingival thickness and esthetics, and evaluation of patient satisfaction in terms of postoperative pain and final esthetic appearance.
The study will be conducted on twelve Egyptian healthy patients with localized gingival recession. Researchers will compare clinical effectiveness of collagen membrane to connective tissue graft in treatment of localized gingival recession. The study hypothesis is that no difference exists between Bilayer collagen membrane combined with Pinhole approach and CT graft combined with Pinhole approach used for root coverage in treatment of localized gingival recession.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Cairo, Egypt
Twenty patients with localized gingival recession were randomly assigned into two equal groups. The control group received treatment with modified Pinhole surgical approach using connective tissue graft material, while the comparison group received treatment with Pinhole surgical approach using collagen membrane. Patients were followed up after 3 and 6 months from treatment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A pinhole is created in the site of recession, the grafting material (Bi-layer collagen membrane versus connective tissue graft) is trimmed to fit the size of the recession defect, followed by graft insertion in the tunnel.
Time frame: The change from enrollment to 24 weeks.
-This clinical parameter will be measured to evaluate the primary outcome: (unit of measurement: millimeters).
Time frame: The change from enrollment to 24 weeks.
This clinical parameter will be measured to evaluate the primary outcome: (unit of measurement: millimeters).
Time frame: This parameter is measured at baseline, 3 and 6 months postoperatively.
Time frame: This parameter is measured at baseline, 3 and 6 months postoperatively.
Time frame: This parameter will be recorded at baseline, 3 and 6 months postoperatively.
Time frame: CAL will be measured at baseline, 3 and 6 months postoperatively.
Time frame: MRC% is recorded at baseline, 3 and 6 months postoperatively.
Percentage of mean root coverage is calculated as: ([RD preoperative - RD postoperative]/ RD preoperative) × 100 % (unit of measurement: Percentage % ).
Time frame: This parameter is measured at baseline, 3 and 6 months postoperatively.
Width of keratinized tissue (KTW) is measured from the most apical extension of gingival margin to the mucogingival line.
Time frame: This parameter is recorded at baseline, 3 and 6 months postoperative.
Gingival thickness (GT) is measured using UNC-15 periodontal probe with piercing the mucosal surface at a right angle with slight pressure until reaching the hard tissue. The distance between the tip of the probe and the outer mark is measured.
Time frame: assessment at two weeks postoperative time.
It's assessed by using verbal, numeric scale and by recording amount of analgesic intake postoperatively. The numerical rating Scale (NRS) pain score: is a psychometric response to pain reported by the patient directly through a score (between 0 and 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain). This was done through a questionnaire two weeks after surgery.
Time frame: The change from enrollment to 24 weeks
The clinical parameter: Root coverage esthetic score (RES) will be measured to evaluate the secondary outcome, time of evaluation at 6 months follow up time.
Ain Shams University
Other
Modified Pinhole Surgical Technique Using Bi-layer Collagen Membrane Versus Subepithelial Connective Tissue Graft in the Treatment of Localized Gingival Recession: A Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07708051
Gingival Diseases, Gingival Recession
View Trial DetailsNCT06871475
Gingival Diseases, Gingival Recession
Minya, Minya Governorate, Egypt
View Trial DetailsNCT07409571
Gingival Diseases, Gingival Recession
Kahramanmaraş, Turkey (Türkiye)
View Trial DetailsNCT07470281
Diabetes Mellitus, Endocrine System Diseases
Lexington, Kentucky, United States
View Trial Details