Trials Sponsors Conditions Drugs Pricing

Conditions

Periodontitis Chronic Generalized Moderate Periodontitis Chronic Generalized Severe

Outcome Measures

Primary Outcomes (5)

Change in probing depths (PD)
PD will be measured from the gingival margin to pocket base using a participant specific fabricated removable resin stent with an assigned #15 UNC probe.
Baseline to 6 months
Change in clinical attachment level (CAL)
CAL will be measured from cemento-enamel junction CEJ to the base of the pocket using the same stent as PD
Baseline to 6 months
Bleeding on probing (BOP)
Bleeding on probing (BOP) will be recorded on an ordinal scale where sites that will bleed on probing will be given a score of 1 while sites that don't bleed will be given a score of 0.
Baseline to 6 months
Plaque index (PI)
PI will be recorded using the Loe and Silness Index. Scores range from 0 - No plaque to 3 - Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Baseline to 6 months
Gingival index
GI will be recorded using the Loe and Silness gingival index. Scores range from 0 - Normal gingiva to 3 - Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.

Study Arms (2)

Autogenous Growth Factors Left Side

EXPERIMENTAL

5-8mm pockets on the left side of the mouth will receive insertion of small treatment after deep cleaning. The right side of the mouth will receive deep cleaning only, the standard of care.

Biological: leukocyte platelet rich fibrin (L-PRF)Procedure: Scaling and Root Planing

Autogenous Growth Factors Right Side

EXPERIMENTAL

5-8mm pockets on the right side of the mouth will receive insertion of small treatment after deep cleaning. The left side of the mouth will receive deep cleaning only, the standard of care.

Biological: leukocyte platelet rich fibrin (L-PRF)Procedure: Scaling and Root Planing

Interventions

leukocyte platelet rich fibrin (L-PRF)Biological

Participants blood will be spun to obtain L-PRF strips and liquid L-PRF. Pockets will receive insertion of small L-PRF strips followed by liquid L-PRF injections to fill the 5-8mm pockets of the test side.

Autogenous Growth Factors Left SideAutogenous Growth Factors Right Side

Scaling and Root PlaningProcedure

Scaling and root planing, which is the standard of care, will be performed on the control side using Cavitron and hand scalers on test and control sides under local anesthesia.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Systemically healthy (ASA 1 or 2) adults over the age of 18
A similar number of bilateral 5-8 mm pocket depths

Sponsors & Collaborators

Virginia Commonwealth University
Otherlead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

MeSH Terms

Interventions

Tooth ExfoliationRoot Planing

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

Thomas Waldrop, DDS
Virginia Commonwealth University
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 16, 2021

First Posted

July 27, 2021

Study Start

May 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

Autogenous Growth Factors Left Side

Autogenous Growth Factors Right Side

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

Autogenous Growth Factors Left Side

Autogenous Growth Factors Right Side

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations