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Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin

Primary Purpose

Periodontal; Lesion, Periodontal Pocket, Molar, Third

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
extraction of mandibular third molar
Sponsored by
University of Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal; Lesion focused on measuring Molar, Third, Platelet-Rich Fibrin

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria Patients of both genders and any race, between 18 and 35 year-old

  • Periodontally health patients and treated periodontally compromised patients
  • Enrollment on a regular supportive periodontal therapy (SPT) program.
  • Full-mouth plaque score (FMPS)< 25% at baseline;
  • Full-mouth bleeding score (FMBS)< 25% at baseline;
  • Patients having bilateral mesioangular impacted mandibular third molars with the presence of a pocket distally to the mandibular second molar with a probing depth (PD) ≥7 mm
  • Intact buccal and lingual cortical bone of the post-extraction site

Exclusion Criteria:

  • General contra-indications for surgery (systemic disease, compromised immune system etc);
  • Tobacco smoking
  • Pregnancy and lactation
  • Untreated periodontal conditions;
  • Acute infection in the site of the extraction
  • Patients taking any medications which might interfere with coagulation
  • Platelet count < 150000/mm3

Sites / Locations

  • Gilberto Sammartino

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRF (platelet-rich fibrin)

spontaneous healing

Arm Description

PRF will be used after the extraction of the third molar to prevent periodontal defects to second molar

after the extraction of the third molar the socket will be left to heal spontaneously

Outcomes

Primary Outcome Measures

Clinical attachment level change
the clinical attachment level is the distance between the gingival margin to the cemento-enamel junction. the measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.

Secondary Outcome Measures

probing depth change
The probing depth is the distance from the free end of the gingival margin to the bottom of the periodontal pocket. The measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.
gingival recession change
The distance between the cemento-enamel junction and gingival margin gives the level of recession. The measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.

Full Information

First Posted
July 22, 2019
Last Updated
March 24, 2020
Sponsor
University of Naples
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1. Study Identification

Unique Protocol Identification Number
NCT04033744
Brief Title
Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin
Official Title
Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 7, 2018 (Actual)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
July 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Naples

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The extraction of deep impacted mandibular third molar may cause periodontal defects at the distal root of the second molar. The aim of this study was to evaluate the ability of platelet-rich fibrin (PRF) in preventing periodontal complications at the distal root of the second molar adjacent to the extracted third molar.
Detailed Description
Eighteen young patients with bilateral impacted mandibular third molars will be selected. All 36 cases of impactions will be selected for a split mouth study and randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 18 cases: in one side the post-extraction socket is left healing spontaneously, on the other side the socket is filled with PRF. CAL at the distal surface of the lower second molar is chosen as primary outcome. Criteria will be the presence of a pocket distal to the mandibular second molar with a probing depth >7 mm and a probing clinical attachment level >6mm. This study was designed as a single-blind research since subjects will be unaware of their treatment allocation. A software will be used to produce a random sequence of 18 integer numbers without duplicates generated from atmospheric noise and concealed in closed envelopes by one of the investigators. At the time of the patient's first surgery, the envelope will be opened and patient allocated either to group 1 (PRF on the right side, spontaneous healing on the left side), for allocation numbers 1-9, or group 2 (spontaneous healing on the right side, PRF on the left side), for allocation numbers 10-18. One clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform all clinical measurements (PD, CAL, gingival recession, plaque index and gingival bleeding index) before and after 12 and 18 weeks of surgery. Clinical and radiographical measurements will be recorded at 12 and 18 weeks after the surgery. The Student t test will be used to compare the differences between the 2 groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal; Lesion, Periodontal Pocket, Molar, Third
Keywords
Molar, Third, Platelet-Rich Fibrin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
One clinician, not involved in patient treatment and not aware of what therapeutic approach was used for the different sites of treatment, performed all clinical measurements (PD, CAL, gingival recession, plaque index and gingival bleeding index) before and after 12 and 18 weeks of surgery.
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRF (platelet-rich fibrin)
Arm Type
Experimental
Arm Description
PRF will be used after the extraction of the third molar to prevent periodontal defects to second molar
Arm Title
spontaneous healing
Arm Type
Active Comparator
Arm Description
after the extraction of the third molar the socket will be left to heal spontaneously
Intervention Type
Procedure
Intervention Name(s)
extraction of mandibular third molar
Intervention Description
After loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised. The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp. The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle. An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary
Primary Outcome Measure Information:
Title
Clinical attachment level change
Description
the clinical attachment level is the distance between the gingival margin to the cemento-enamel junction. the measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.
Time Frame
12 and 18 weeks
Secondary Outcome Measure Information:
Title
probing depth change
Description
The probing depth is the distance from the free end of the gingival margin to the bottom of the periodontal pocket. The measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.
Time Frame
12 and 18 weeks
Title
gingival recession change
Description
The distance between the cemento-enamel junction and gingival margin gives the level of recession. The measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.
Time Frame
12 and 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria Patients of both genders and any race, between 18 and 35 year-old Periodontally health patients and treated periodontally compromised patients Enrollment on a regular supportive periodontal therapy (SPT) program. Full-mouth plaque score (FMPS)< 25% at baseline; Full-mouth bleeding score (FMBS)< 25% at baseline; Patients having bilateral mesioangular impacted mandibular third molars with the presence of a pocket distally to the mandibular second molar with a probing depth (PD) ≥7 mm Intact buccal and lingual cortical bone of the post-extraction site Exclusion Criteria: General contra-indications for surgery (systemic disease, compromised immune system etc); Tobacco smoking Pregnancy and lactation Untreated periodontal conditions; Acute infection in the site of the extraction Patients taking any medications which might interfere with coagulation Platelet count < 150000/mm3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilberto Sammartino, Professor
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gilberto Sammartino
City
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28635382
Citation
Cabaro S, D'Esposito V, Gasparro R, Borriello F, Granata F, Mosca G, Passaretti F, Sammartino JC, Beguinot F, Sammartino G, Formisano P, Riccitiello F. White cell and platelet content affects the release of bioactive factors in different blood-derived scaffolds. Platelets. 2018 Jul;29(5):463-467. doi: 10.1080/09537104.2017.1319046. Epub 2017 Jun 21.
Results Reference
result
PubMed Identifier
21718187
Citation
Sammartino G, Dohan Ehrenfest DM, Carile F, Tia M, Bucci P. Prevention of hemorrhagic complications after dental extractions into open heart surgery patients under anticoagulant therapy: the use of leukocyte- and platelet-rich fibrin. J Oral Implantol. 2011 Dec;37(6):681-90. doi: 10.1563/AAID-JOI-D-11-00001. Epub 2011 Jun 30.
Results Reference
result
PubMed Identifier
15944972
Citation
Sammartino G, Tia M, Marenzi G, di Lauro AE, D'Agostino E, Claudio PP. Use of autologous platelet-rich plasma (PRP) in periodontal defect treatment after extraction of impacted mandibular third molars. J Oral Maxillofac Surg. 2005 Jun;63(6):766-70. doi: 10.1016/j.joms.2005.02.010.
Results Reference
result

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Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin

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