Periodontal Pocket Clinical Trial
Official title:
Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin
NCT number | NCT04033744 |
Other study ID # | 56/15 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 7, 2018 |
Est. completion date | July 19, 2019 |
Verified date | July 2019 |
Source | University of Naples |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | July 19, 2019 |
Est. primary completion date | July 19, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Gilberto Sammartino | Naples |
Lead Sponsor | Collaborator |
---|---|
University of Naples |
Italy,
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 sca — View 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. 20 — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
12 and 18 weeks | |
Secondary | 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. | 12 and 18 weeks | |
Secondary | 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. |
12 and 18 weeks |
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