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OpenTrials
Completed

NCT Number: NCT04314726

Verify if Amelogenins Had Some Benefits in Improving Lower 2nd Molar Periodontal Healing After 3rd Molar Extraction

Background: Prevention of periodontal defects after the extraction of lower third molars remains a challenge. Various methods have been proposed in the literature, but there are no studies which evaluated the effectiveness of amelogenins.

Methods: A single-blind split-mouth randomized controlled clinical trial (RCT) was performed on 5 patients to verify if amelogenins had some benefits in improving lower second molar periodontal healing after adjacent third molar extraction. A PPD ≥ 8 mm associated with a radiographic bone defect of at least 5 mm were the main inclusion criteria.

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Key information

Conditions

Attachment Loss, Periodontal Mouth Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Diseases Periodontal Pocket Periodontitis Stomatognathic Diseases Teeth, Impacted Tooth Diseases Tooth, Impacted

Age range

18 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients aged < 27, for which the extraction of both lower third molars was indicated
  • Bilateral total (bone or osteo-mucosal) third molar impaction
  • Bilateral bone defect ≥ 5mm distal to the lower second molars, evaluated on pre- operative periapical radiographs performed with Rinn's film holders
  • PPD ≥ 8mm distal to the second lower molars, in at least one of the following probing sites: buccal, disto-buccal, disto-central, disto-lingual
  • Intra-operative integrity of both third molar buccal and lingual alveolar cortices

Exclusion criteria

  • Smoking habit
  • Systemic disorders with serious immunologic impairment
  • Taking cortisone or other drugs that might interfere with healing process
  • Allergy to penicillins
  • Previous periodontal treatment
  • Less than 2 mm of adherent gingiva at second molar level
  • Second molars with a prosthetic crown
  • Previous endodontic treatment of second molars
  • Furcation involvement of the second molars

Treatment and study plan

Amelogenin

Drug

amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction

Other names: third molar surgery

Placebos

Drug

placebo applied on the distal surface of the lower second molar after adjacent third molar extraction

Other names: third molar surgery

Primary outcomes

  1. CAL (Clinical attachment level) pre operative

    Time frame: baseline, pre-surgery

  2. CAL (Clinical attachment level) post operative

    Time frame: 7 days after surgery

  3. CAL (Clinical attachment level) 3 months

    Time frame: 3 months after surgery.

  4. CAL (Clinical attachment level) 12 months

    Time frame: 12 months after surgery.

  5. PPD (Periodontal probing dept) pre operative

    Time frame: baseline, pre-surgery

  6. PPD (Periodontal probing dept) post operative

    Time frame: 7 days after surgery

  7. PPD (Periodontal probing dept) 3 months

    Time frame: 3 months after surgery.

  8. PPD (Periodontal probing dept) 12 months

    Time frame: 12 months after surgery.

  9. REC (recession) pre operative

    Time frame: baseline, pre-surgery

  10. REC (recession) post operative

    Time frame: 7 days after surgery

  11. REC (recession) 3 months

    Time frame: 3 months after surgery.

  12. REC (recession) 12 months

    Time frame: 12 months after surgery.

  13. Radiographic bone Level pre operative

    Time frame: An endoral x-ray was taken baseline, pre-surgery

  14. Radiographic bone Level post operative

    Time frame: An endoral x-ray was taken 7 days after surgery

  15. Radiographic bone Level 3 months

    Time frame: An endoral x-ray was taken 3 months after surgery.

  16. Radiographic bone Level 12 months

    Time frame: An endoral x-ray was taken 12 months after surgery.

Secondary outcomes

  1. Adverse Events pre operative

    Time frame: pre-operative

    the occurrence of adverse events after the use of amelogenins.

  2. Adverse Events post operative

    Time frame: 7 days after surgery

    the occurrence of adverse events after the use of amelogenins.

  3. Adverse Events 3 months

    Time frame: 3 months after surgery.

    the occurrence of adverse events after the use of amelogenins.

  4. Adverse Events 12 months

    Time frame: 12 months after surgery.

    the occurrence of adverse events after the use of amelogenins.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Usefulness of Amelogenins in the Treatment of Periodontal Defects on the Distal Surface of the Lower Second Molar After Adjacent Third Molar Extraction: a Pilot Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2020
Registry last updated
Mar 19, 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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