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

March 17, 2020 updated by: Pippi Roberto, University of Roma La Sapienza

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 27 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: amelogenins group
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
Drug: Amelogenin
amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction
Other Names:
  • third molar surgery
Placebo Comparator: placebo group
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
Drug: Placebos
placebo applied on the distal surface of the lower second molar after adjacent third molar extraction
Other Names:
  • third molar surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
CAL (Clinical attachment level) pre operative
Time Frame: baseline, pre-surgery
baseline, pre-surgery
CAL (Clinical attachment level) post operative
Time Frame: 7 days after surgery
7 days after surgery
CAL (Clinical attachment level) 3 months
Time Frame: 3 months after surgery.
3 months after surgery.
CAL (Clinical attachment level) 12 months
Time Frame: 12 months after surgery.
12 months after surgery.
PPD (Periodontal probing dept) pre operative
Time Frame: baseline, pre-surgery
baseline, pre-surgery
PPD (Periodontal probing dept) post operative
Time Frame: 7 days after surgery
7 days after surgery
PPD (Periodontal probing dept) 3 months
Time Frame: 3 months after surgery.
3 months after surgery.
PPD (Periodontal probing dept) 12 months
Time Frame: 12 months after surgery.
12 months after surgery.
REC (recession) pre operative
Time Frame: baseline, pre-surgery
baseline, pre-surgery
REC (recession) post operative
Time Frame: 7 days after surgery
7 days after surgery
REC (recession) 3 months
Time Frame: 3 months after surgery.
3 months after surgery.
REC (recession) 12 months
Time Frame: 12 months after surgery.
12 months after surgery.
Radiographic bone Level pre operative
Time Frame: An endoral x-ray was taken baseline, pre-surgery
An endoral x-ray was taken baseline, pre-surgery
Radiographic bone Level post operative
Time Frame: An endoral x-ray was taken 7 days after surgery
An endoral x-ray was taken 7 days after surgery
Radiographic bone Level 3 months
Time Frame: An endoral x-ray was taken 3 months after surgery.
An endoral x-ray was taken 3 months after surgery.
Radiographic bone Level 12 months
Time Frame: An endoral x-ray was taken 12 months after surgery.
An endoral x-ray was taken 12 months after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events pre operative
Time Frame: pre-operative
the occurrence of adverse events after the use of amelogenins.
pre-operative
Adverse Events post operative
Time Frame: 7 days after surgery
the occurrence of adverse events after the use of amelogenins.
7 days after surgery
Adverse Events 3 months
Time Frame: 3 months after surgery.
the occurrence of adverse events after the use of amelogenins.
3 months after surgery.
Adverse Events 12 months
Time Frame: 12 months after surgery.
the occurrence of adverse events after the use of amelogenins.
12 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Roma La Sapienza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roberto Pippi, MDDS, Sapienza University of Rome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3522/13.02.2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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