Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05389059
Other study ID # 519622
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 25, 2022
Est. completion date September 1, 2023

Study information

Verified date May 2022
Source University of Baghdad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date September 1, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region. - The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures. - All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession - All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with . - All patients at least 18 years of age and of both genders. Exclusion Criteria: - Smoker Patients . - Patients with diabetes. - Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy. - pregnant or nursing women. - Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs). - Patients with a disease affecting connective tissue metabolism. - Patients allergic to collagen.

Study Design


Intervention

Procedure:
CAF+CM
Periodontal surgery including CAF+CM application
I-PRF
Periodontal surgery including CAF+CM application with i-PRF

Locations

Country Name City State
Iraq University of Baghdad / College of Dentistry Baghdad

Sponsors (1)

Lead Sponsor Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1 The primary outcome of the study is the reduction in gingival recession depth on the buccal sides of RT1 gingival recession, between the baseline preoperative measurement and follow-up at 3 months and 6 months. The Recession Depth (RD) is Measured in millimeter (mm) from CEJ (Cemento-Enamel-Junction) to the gingival margin using UNC-15 probe. Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Secondary Improvement in Gingival Thickness (GT) Gingival Thickness (GT) is determined at 1.5 mm apical to the gingival margin using a caliper (endodontic reamer#20) rounded to the nearest 0.1mm. Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Secondary Improvement in the Keratinized Tissue Height (KTH) Keratinized Tissue Height (KTH) is measured in millimeters (mm) taken at the mid buccal aspect of the involved teeth from the gingival margin to the muco-gingival junction, by a manual periodontal probe (UNC-15 probe,Hu-Friedy,Chicago,USA). Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Secondary Reduction in the Recession Width (RW) Recession Width (RW) is measured in millimeter (mm) at the Cement-Enamel Junction (CEJ) using UNC-15 probe. Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Secondary Reduction in Probing Pocket Depth (PPD) Probing Pocket Depth (PPD) is measured in millimeter (mm) from the gingival margin to the apical extend of the probe. Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Secondary Reduction Clinical Attachment Level (CAL) Clinical Attachment Level (CAL) is measured in millimeter (mm) from the CEJ to the apical extend of the probe. Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Secondary Measuring Plaque-Index (PI) Plaque-Index (PI) is measured as a percentage of the presence of Plaque on four surfaces of the teeth using a manual periodontal probe. Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Secondary Measuring Bleeding On Probing (BOP) Bleeding On Probing (BOP) is measured as a percentage of sites with bleeding on probing using a manual periodontal probe. Between the baseline preoperative measurement and follow-up at 3 months and 6 months
See also
  Status Clinical Trial Phase
Completed NCT04813302 - Influence of Anatomical Factors Upon Root Coverage N/A
Completed NCT04977778 - Effectiveness in Dental Plaque Reduction of Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride N/A
Completed NCT04293718 - Acquired Chronic Erosive Gingivitis: Clinical Relevance of Papillary Gingival Biopsy
Completed NCT00966953 - Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing. Phase 3
Completed NCT00391547 - Pilot Efficacy Study to Treat Gingivitis Phase 2
Completed NCT03027908 - A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period N/A
Recruiting NCT05384132 - Novel Dental Gel as an Adjunct to Scaling and Root Planing N/A
Active, not recruiting NCT06079307 - Effect of Oxygenated Mouthwash and Mouth Foam N/A
Completed NCT03364751 - Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome N/A
Completed NCT01952301 - Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation N/A
Recruiting NCT04905784 - The Impact of Simple Home-based Differential Learning on Oral Hygiene in Children. N/A
Not yet recruiting NCT06381700 - Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children: N/A
Completed NCT00758290 - Clinical Study to Evaluate Dental Plaque Phase 3
Recruiting NCT04957342 - Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery N/A
Completed NCT04003493 - LifE Style, Nutrition and Oral Health in Care Givers (LENTO) N/A
Completed NCT02774967 - Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions N/A
Completed NCT02229669 - Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions N/A
Completed NCT00761930 - Compare the Clinical Efficacy of Prototype Toothpastes. Phase 3
Completed NCT00763048 - Collection of Gingival Crevicular Fluid From Periodontitis Patients Phase 3
Recruiting NCT06351982 - Treatment Of Shallow Periodontal Pockets 4-6mm Using AIRFLOW Prophylaxis Master Device With Erythritol vs Manual Scalers N/A