Clinical and Radiographic Evaluation of Demineralized Freeze-Dried Bone Allograft Versus Platelet Rich Fibrin for the Treatment of Periodontal Intrabony Defects in Humans

NCT02154906 | Completed Results

• 1 other identifier: HSC20130439H
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory periodontal disease often results in loss of bone around the teeth. Bone defects that have a certain size and shape (called intrabony or intraosseous defects) may be improved by using a graft material in the bony defect. The purpose of this study is to compare healing of periodontal intrabony defects that are treated using demineralized freeze dried bone allograft (DFDBA) versus autogenous platelet-rich fibrin. The null hypotheses is that there will be no significant differences in bone fill, CAL gain, PD reduction or recession at sites treated with PRF compared to sites treated with DFDBA.

Conditions

Periodontitis

Keywords

periodontal disease; periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Attachment Level (CAL)

  measurement of CAL at the time of surgical intervention will be compared with measurement of CAL and bone level 6 months after surgery

  baseline and 6 months after surgery

Secondary Outcomes (1)

• Change in Radiographic Bone Level

  baseline and 6 months after surgery

Study Arms (2)

DFDBA

ACTIVE COMPARATOR

DFDBA used to graft intrabony defect

Device: DFDBA

autologous platelet rich fibrin

EXPERIMENTAL

autologous platelet rich fibrin used to graft intrabony defect

Device: autologous platelet rich fibrin

Interventions

DFDBA DEVICE

DFDBA

autologous platelet rich fibrin DEVICE

autologous platelet rich fibrin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient currently a patient at dental school or eligible for treatment at dental school
• Patient resides within 50 mile radius of dental school and is eligible for treatment in Graduate Periodontics Clinic
• Diagnosis of chronic periodontitis with a treatment plan that includes surgical treatment of an intrabony defect adjacent to a natural tooth
• Willing and able to provide informed consent and be available for multiple follow-up visits for the duration of the study
• One or more sites with 1) a probing depth of 6mm or greater (\>6mm), 2) a radiographic bony defect depth of greater than 3mm (\>3mm), 3) sufficient keratinized tissue to allow complete coverage of the defect with gingival flaps, and 4) radiographic base of bony defect at least 2mm coronal to the apex of the tooth
• Female patients who have undergone a hysterectomy, tubal ligation or menopause, and non-pregnant women of child-bearing potential

You may not qualify if:

• Failure to attain adequate oral hygiene prior to surgery (minimum 80% plaque-free surfaces)
• History within the last 6 months of daily use of smokeless tobacco, pipe or cigar smoking, or cigarette smoking exceeding 10 cigarettes per day. Former smokers who quit more than 6 months before the study are eligible for enrollment. Current smokers who smoke less than 10 cigarettes per day are eligible for enrollment.
• Untreated acute or chronic infections in the region of the study site
• Tooth mobility of Grade 2 or higher at the tooth with the potential test site
• Clinical or radiographic signs of apical pathology, root fracture, untreated carious lesions on the root surface or at the CEJ, subgingival restorations on the tooth with the potential test site
• Sensitivity or allergy to Bacitracin, Gentamycin, Polymyxin B Sulfate, alcohol and/or surfactants

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health Science Center School of Dentistry

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Chadwick JK, Mills MP, Mealey BL. Clinical and Radiographic Evaluation of Demineralized Freeze-Dried Bone Allograft Versus Platelet-Rich Fibrin for the Treatment of Periodontal Intrabony Defects in Humans. J Periodontol. 2016 Nov;87(11):1253-1260. doi: 10.1902/jop.2016.160309. Epub 2016 Jun 28.

  PMID: 27353441 DERIVED

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Brian L. Mealey
• Organization: UT Health Science Center San Antonio

mealey@uthscsa.edu

210-567-3567

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 3, 2014
• Study Start: November 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 1, 2016
• Results First Posted: June 1, 2016

Record last verified: 2016-06

Locations

US (1)