NCT03707483

Brief Summary

This study is meant to assess clinically the possible predictable clinical attachment gain regarding the use of vitamin C with platelet rich fibrin versus platelet rich fibrin alone in the treatment of periodontal intrabony defects

Trial Health

35
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 phase_2

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_2

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

October 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 7, 2019

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

October 12, 2018

Last Update Submit

February 6, 2019

Conditions

Periodontal Bone Loss

Outcome Measures

Primary Outcomes (1)

  • gain in clinical attachment level

    Measured from the CEJ to the bottom of the gingival sulcus

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

250 μM of vitamin C will be used with the platelet rich fibrin

Combination Product: combination of vitamin C and platelet rich fibrin

Comparator

ACTIVE COMPARATOR

using platelet rich fibrin alone

Combination Product: combination of vitamin C and platelet rich fibrin

Interventions

combination of vitamin C and platelet rich fibrinCOMBINATION_PRODUCT

combination of vitamin C and platelet rich fibrin

ComparatorIntervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient consulting in the outpatient clinic.
  • Able to tolerate surgical periodontal procedures.
  • Patient ready to perform oral hygiene instructions.
  • Compliance with the maintenance program.
  • Provide informed consent.
  • Accept the 6 months follow-up period
  • Mature permanent tooth.
  • Tooth with two or three-walled intra-bony defect, CAL ≥ 5mm with intra-osseous defect ≥ 3mm.

You may not qualify if:

  • Medically compromised patients.
  • Pregnant or nursing women.
  • Uncooperative patients.
  • Smokers.
  • Teeth with one wall intra-bony defect.
  • Teeth with supra-bony defects.
  • Teeth with grade III mobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 16, 2018

Study Start

February 1, 2019

Primary Completion

November 1, 2019

Study Completion

March 1, 2020

Last Updated

February 7, 2019

Record last verified: 2018-10