Attachment Loss, PeriodontalPhase 4NCT04314726
Verify if Amelogenins Had Some Benefits in Improving Lower 2nd Molar Periodontal Healing After 3rd Molar Extraction
A Phase 4 study testing Amelogenin in people with Attachment Loss, Periodontal and Teeth, Impacted, run by University of Roma La Sapienza.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Attachment Loss, Periodontal, Teeth, Impacted
- What is being tested?
- Amelogenin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 24 Mar 2016to 20 Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Second molars with a prosthetic crown
- Previous endodontic treatment of second molars
- Furcation involvement of the second molars
About this study
Official 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
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.
- Conditions
- Attachment Loss, Periodontal, Teeth, Impacted
- Being tested
- Amelogenin, Placebos
- Keywords
- third molar surgery, amelogenin, periodontal pocket
- Medical subject headings
- Periodontal Attachment Loss, Tooth, Impacted, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmelogeninDrug
Also called third molar surgery
amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction
PlacebosDrug
Also called third molar surgery
placebo applied on the distal surface of the lower second molar after adjacent third molar extraction
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Amelogenin |
| 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 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAL (Clinical attachment level) pre operative
Measured: baseline, pre-surgery
CAL (Clinical attachment level) post operative
Measured: 7 days after surgery
CAL (Clinical attachment level) 3 months
Measured: 3 months after surgery.
CAL (Clinical attachment level) 12 months
Measured: 12 months after surgery.
PPD (Periodontal probing dept) pre operative
Measured: baseline, pre-surgery
PPD (Periodontal probing dept) post operative
Measured: 7 days after surgery
PPD (Periodontal probing dept) 3 months
Measured: 3 months after surgery.
PPD (Periodontal probing dept) 12 months
Measured: 12 months after surgery.
REC (recession) pre operative
Measured: baseline, pre-surgery
REC (recession) post operative
Measured: 7 days after surgery
REC (recession) 3 months
Measured: 3 months after surgery.
REC (recession) 12 months
Measured: 12 months after surgery.
Radiographic bone Level pre operative
Measured: An endoral x-ray was taken baseline, pre-surgery
Radiographic bone Level post operative
Measured: An endoral x-ray was taken 7 days after surgery
Radiographic bone Level 3 months
Measured: An endoral x-ray was taken 3 months after surgery.
Radiographic bone Level 12 months
Measured: An endoral x-ray was taken 12 months after surgery.
Secondary outcomes (4)
Adverse Events pre operative
the occurrence of adverse events after the use of amelogenins.
Measured: pre-operative
Adverse Events post operative
the occurrence of adverse events after the use of amelogenins.
Measured: 7 days after surgery
Adverse Events 3 months
the occurrence of adverse events after the use of amelogenins.
Measured: 3 months after surgery.
Adverse Events 12 months
the occurrence of adverse events after the use of amelogenins.
Measured: 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start24 Mar 2016
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attachment Loss, PeriodontalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, split-mouth, placebo-controlled, single blind clinical trial, a pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pippi Roberto, University of Roma La Sapienza
- Investigators
- Roberto Pippi, MDDS, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314726
- Sponsor's protocol ID
- 3522/13.02.2015
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04314726
- Acronym / sponsor ID
- 3522/13.02.2015
- Conditions
- Attachment Loss, Periodontal, Teeth, Impacted
- Keywords
- third molar surgery, amelogenin, periodontal pocket
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized, split-mouth, placebo-controlled, single blind clinical trial, a pilot study
| Arm | Type | Receives |
|---|---|---|
| amelogenins group | Active comparator | Drug: AmelogeninThe 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 | Drug: PlacebosThe 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 |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmelogeninAlso: third molar surgeryamelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction | Drug | amelogenins group |
| PlacebosAlso: third molar surgeryplacebo applied on the distal surface of the lower second molar after adjacent third molar extraction | Drug | placebo group |
Primary outcome
CAL (Clinical attachment level) pre operative
Time frame: baseline, pre-surgery
CAL (Clinical attachment level) post operative
Time frame: 7 days after surgery
CAL (Clinical attachment level) 3 months
Time frame: 3 months after surgery.
CAL (Clinical attachment level) 12 months
Time frame: 12 months after surgery.
PPD (Periodontal probing dept) pre operative
Time frame: baseline, pre-surgery
PPD (Periodontal probing dept) post operative
Time frame: 7 days after surgery
PPD (Periodontal probing dept) 3 months
Time frame: 3 months after surgery.
PPD (Periodontal probing dept) 12 months
Time frame: 12 months after surgery.
REC (recession) pre operative
Time frame: baseline, pre-surgery
REC (recession) post operative
Time frame: 7 days after surgery
REC (recession) 3 months
Time frame: 3 months after surgery.
REC (recession) 12 months
Time frame: 12 months after surgery.
Radiographic bone Level pre operative
Time frame: 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
Radiographic bone Level 3 months
Time frame: 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.
4 secondary outcomes
Adverse Events pre operative
Time frame: pre-operative
Adverse Events post operative
Time frame: 7 days after surgery
Adverse Events 3 months
Time frame: 3 months after surgery.
Adverse Events 12 months
Time frame: 12 months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Pippi, MDDS principal investigator
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amelogenin in people with Attachment Loss, Periodontal and Teeth, Impacted, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAL (Clinical attachment level) pre operative (time frame: baseline, pre-surgery). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.