NCT05389059

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

April 24, 2022

Last Update Submit

May 20, 2022

Conditions

Gingival DiseasesTraumatic Injury

Keywords

Gingival RecessionCollagen MatrixPlasma rich proten

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Improvement in Gingival Thickness (GT)

    Between the baseline preoperative measurement and follow-up at 3 months and 6 months

  • Improvement in the Keratinized Tissue Height (KTH)

    Between the baseline preoperative measurement and follow-up at 3 months and 6 months

  • Reduction in the Recession Width (RW)

    Between the baseline preoperative measurement and follow-up at 3 months and 6 months

  • Reduction in Probing Pocket Depth (PPD)

    Between the baseline preoperative measurement and follow-up at 3 months and 6 months

  • Reduction Clinical Attachment Level (CAL)

    Between the baseline preoperative measurement and follow-up at 3 months and 6 months

  • +2 more secondary outcomes

Study Arms (2)

Control arm

OTHER

Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession.

Procedure: CAF+CM

Experimental arm

OTHER

Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession.

Procedure: CAF+CMProcedure: I-PRF

Interventions

CAF+CMPROCEDURE

Periodontal surgery including CAF+CM application

Control armExperimental arm
I-PRFPROCEDURE

Periodontal surgery including CAF+CM application with i-PRF

Experimental arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Baghdad / College of Dentistry

Baghdad, 10047, Iraq

Location

MeSH Terms

Conditions

Gingival DiseasesWounds and InjuriesGingival Recession

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Basima Gh Ali, MSc

    University of Baghdad

    PRINCIPAL INVESTIGATOR

  • Thair AL Hassan, PHD

    University of Baghdad

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD student

Study Record Dates

First Submitted

April 24, 2022

First Posted

May 24, 2022

Study Start

April 25, 2022

Primary Completion

March 30, 2023

Study Completion

September 1, 2023

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)