Attachment Loss, Periodontal, Teeth, Impacted
Conditions
Keywords
third molar surgery, amelogenin, periodontal pocket
Brief summary
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.
Interventions
DRUGAmelogenin
amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction
DRUGPlacebos
placebo applied on the distal surface of the lower second molar after adjacent third molar extraction
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A randomized, split-mouth, placebo-controlled, single blind clinical trial, a pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 27 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic bone Level 12 months | An endoral x-ray was taken 12 months after surgery. |
| REC (recession) 12 months | 12 months after surgery. |
| Radiographic bone Level pre operative | An endoral x-ray was taken baseline, pre-surgery |
| Radiographic bone Level post operative | An endoral x-ray was taken 7 days after surgery |
| Radiographic bone Level 3 months | An endoral x-ray was taken 3 months after surgery. |
| CAL (Clinical attachment level) pre operative | baseline, pre-surgery |
| CAL (Clinical attachment level) post operative | 7 days after surgery |
| CAL (Clinical attachment level) 3 months | 3 months after surgery. |
| CAL (Clinical attachment level) 12 months | 12 months after surgery. |
| PPD (Periodontal probing dept) pre operative | baseline, pre-surgery |
| PPD (Periodontal probing dept) post operative | 7 days after surgery |
| PPD (Periodontal probing dept) 3 months | 3 months after surgery. |
| PPD (Periodontal probing dept) 12 months | 12 months after surgery. |
| REC (recession) pre operative | baseline, pre-surgery |
| REC (recession) post operative | 7 days after surgery |
| REC (recession) 3 months | 3 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events post operative | 7 days after surgery | the occurrence of adverse events after the use of amelogenins. |
| Adverse Events 3 months | 3 months after surgery. | the occurrence of adverse events after the use of amelogenins. |
| Adverse Events 12 months | 12 months after surgery. | the occurrence of adverse events after the use of amelogenins. |
| Adverse Events pre operative | pre-operative | the occurrence of adverse events after the use of amelogenins. |
Outcome results
None listed