Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05370456
Other study ID # XCM+HA_Turin
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 3, 2022
Est. completion date September 10, 2024

Study information

Verified date May 2022
Source University of Turin, Italy
Contact Mario Aimetti, PA
Phone 00390116331541
Email mario.aimetti@unito.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of this study is to evaluate whether the effect of HA in combination with XCM for the treatment of MAGRs with a multiple coronally advanced flap technique (mCAF) achieves better results than the XCM with mCAF alone in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding) and lastly the expression of molecular mediators of tissue healing/regeneration. The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM+HA is superior to the mCAF with only XCM in terms of recessions reduction and secondary clinical variables, including PROMs.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 10, 2024
Est. primary completion date September 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years old and able to sign informed consent - At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of =2mm with indication for root coverage treatment - A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest - Available to attend study related procedures (including follow-up visits) Exclusion Criteria: - Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus); - Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers; - Pregnant or nursing women; - History of previous periodontal surgery (mucogingival or other) on the teeth to be included; - Furcation involvement in the teeth to be included; - Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated; - Presence of fixed or removable prosthesis in the area to be treated

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM
After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction and HA gel will be applied.
Procedure:
Treatment of MAGRs with mCAF technique and XCM
After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.

Locations

Country Name City State
Italy University of Turin Turin

Sponsors (1)

Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Recession Reduction (RecRed) Mean changes in mm in recession depth between baseline and 1-year 6 months; 1 year
Secondary Complete Root Coverage (CRC) Percentage of sites with complete root coverage after 1-year 6 months; 1 year
Secondary Mean Root Coverage (MRC) Percentage of mean root coverage after 1-year 6 months; 1 year
Secondary Keratinised tissue height (KTH) changes Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year 6 months; 1 year
Secondary Post-operative morbidity (pain, swelling, discomfort) Assessment of patient's pain, swelling and discomfort at 14 days after the procedure using visual analogue scale (VAS) ranging from 0 (no pain, swelling or discomfort) to 10 (maximum pain, swelling or discomfort) with a questionnaire 14 days
See also
  Status Clinical Trial Phase
Completed NCT02987231 - Electrical Stimulation Effect on Coronally Advanced Flap N/A
Recruiting NCT06409468 - NovoMatrix in Gingival Recession Coverage: Case Series N/A
Completed NCT03207984 - Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions N/A
Recruiting NCT03619096 - Two Different Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix N/A
Withdrawn NCT03954028 - The Healing of Soft Tissue Augmentation by Acellular Dermal Matrix and Autogenous Subepithelial Connective Tissue Graft N/A
Completed NCT03043638 - Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions N/A
Recruiting NCT03037320 - Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial N/A
Completed NCT03883438 - Cor Adv Flap Plus Ac Derm Matrix in Thin Phenotype Multiple Recessions N/A
Recruiting NCT03207971 - ASSESSMENT OF CLINICAL PARAMETERS AND LASER DOPPLER FLOWMETRY FOR THE TREATMENT OF MULTIPLE GENGIVAL RECESSIONS WITH TWO TYPES OF SUBEPITELIAL CONNECTIVE GRAFT: RANDOMIZED CLINICAL STUDY N/A
Recruiting NCT05693753 - Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions N/A
Completed NCT04093674 - Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG N/A
Completed NCT03462368 - Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Adjunctive Therapies N/A