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NCT Number: NCT04033744

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

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.

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Key information

Conditions

Periodontal; Lesion Molar, Third Mouth Diseases Periodontal Diseases Periodontal Pocket Periodontitis Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gilberto Sammartino

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extraction of mandibular third molar

Procedure

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 outcomes

  1. Clinical attachment level change

    Time frame: 12 and 18 weeks

    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 outcomes

  1. probing depth change

    Time frame: 12 and 18 weeks

    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.

  2. gingival recession change

    Time frame: 12 and 18 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Naples

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2019
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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