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

NCT04978324 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: HM20021781
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to find out about the effect of growth factors extracted from blood on improving healing of periodontal pockets (Gum pockets) after deep gum cleaning.

Conditions

Periodontitis Chronic Generalized Severe; Periodontitis Chronic Generalized Moderate

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.

  Baseline to 6 months

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 Side; Autogenous Growth Factors Right Side

Scaling and Root Planing PROCEDURE

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.

Autogenous Growth Factors Left Side; Autogenous Growth Factors Right Side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• Diagnosed with Stage II or Stage III chronic periodontitis.

You may not qualify if:

• Uncontrolled systemic illness that may affect healing or clotting such as diabetes mellitus, immunocompromisation, bleeding disorders, ongoing chemo- or radiotherapy
• Active smokers
• Pregnancy
• Periodontal treatment in the last six months
• Antibiotic therapy within three months prior to treatment
• Taking medications that could affect periodontal status or healing

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

Tooth Exfoliation; Root Planing

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Thomas Waldrop, DDS

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

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 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)