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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amelogenins group | Active Comparator | The study involved enrolling 5 periodontitis free patients, to which the extraction of both lower third molars was prescribed. A bone defect at the distal surface of the second molar ≥ 5 mm, had to be present on the intraoral periapical radiography, bilaterally. Amelogenins effect was evaluated by applying them only in the test site and comparing healing results with those obtained on the contra-lateral site |
|
| placebo group | Placebo Comparator | The study involved enrolling 5 periodontitis free patients, to which the extraction of both lower third molars was prescribed. A bone defect at the distal surface of the second molar ≥ 5 mm, had to be present on the intraoral periapical radiography, bilaterally. In this group (control site) the conventional treatment was performed, and healing was ensured only by the simple blood clot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amelogenin | Drug | amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events pre operative | the occurrence of adverse events after the use of amelogenins. | pre-operative |
| Adverse Events post operative | the occurrence of adverse events after the use of amelogenins. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Pippi, MDDS | University of Roma La Sapienza | Principal Investigator |
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| ID | Term |
|---|---|
| D017622 | Periodontal Attachment Loss |
| D014095 | Tooth, Impacted |
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D053523 | Amelogenin |
| ID | Term |
|---|---|
| D003746 | Dental Enamel Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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A randomized, split-mouth, placebo-controlled, single blind clinical trial, a pilot study
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| Placebos | Drug | placebo applied on the distal surface of the lower second molar after adjacent third molar extraction |
|
|
| 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. |
| Radiographic bone Level 12 months | An endoral x-ray was taken 12 months after surgery. |
| 7 days after surgery |
| Adverse Events 3 months | the occurrence of adverse events after the use of amelogenins. | 3 months after surgery. |
| Adverse Events 12 months | the occurrence of adverse events after the use of amelogenins. | 12 months after surgery. |
| D014076 |
| Tooth Diseases |
| D010518 | Periodontitis |