Bone InjuryPhase 4salivaryBMP2NCT05369091
Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density at Extracted Tooth
A Phase 4 study testing Simvastatin 10mg in people with Bone Injury, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
Trial summary
Salivary Bmp-2 Levels \& Radiographic Measurement Of Bone Density were evaluated At Extracted Tooth Socket in patients With \& Without topical Application Of Simvastatin Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Injury
- What is being tested?
- Simvastatin 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Dec 2020to 5 Jan 2022
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female patients with permanent dentition, age (18 years to 25 years) were considered.
- Patients undergoing extraction of maxillary or mandibular Pre molars for orthodontic procedure.
- Teeth which required only simple non surgical extraction only under local anesthesia.
Who cannot join
- Subjects taking antibiotics or non-steroidal anti inflammatory drugs (NSAIDS) within one week.
- Patients with oral mucosal lesions (leukoplakia, erythroplakia, lichen planus).
- Patients with oral carcinoma.
- Patients with xerostomia.
- Previous history of radiotherapy or chemotherapy
- Patient with known hypersensitivity to anti inflammatory drugs.
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- Diabetic patients.
- Pregnant and lactating patients.
- Patients with social habits such as cigarette smoking and alcohol consumption.
- Teeth radiographically involved in any abscess/cyst/granuloma.
- Teeth requiring open surgical transalveolar extraction.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dental Department of Lahore General Hospital.
Lahore, Punjab Province
About this study
Official title: Salivary Bmp-2 Levels And Radiographic Measurement Of Bone Density At Extracted Tooth Socket In Patients With And Without Topical Application Of Simvastatin
Salivary Bmp-2 Levels \& Radiographic Measurement Of Bone Density were evaluated At Extracted Tooth Socket in patients With \& Without topical Application Of Simvastatin
Read the detailed description
Objective: The objective of this study was to compare:
'The salivary BMP-2 levels in the experimental and the control groups with and without topical simvastatin application on wound of extracted tooth socket.
The bone density at extracted tooth socket by measuring mean gray value from Intra oral periapical (IOPA) radiographs in the experimental and the control groups.
Method: Twenty four patients either male or female without any systemic disease, aged between 18 years to 25 years were selected. The patients were equally divided by random computer generated numbers into experimental and control groups. In the experimental group, tooth extraction was followed by placement of simvastatin (containing 10 mg of drug). In the control group, only tooth extraction was done. Saliva sample was collected from patients on days 0, 3, 7 and 40 and levels of salivary biomarker BMP-2 were measured with the ELISA technique. IOPA radiographs were taken on days 0 and 40 to determine the bone density by measuring mean gray values with the help of ImageJ software. The data was entered in SPSS version 25 and analyzed. P-value of ≤ 0.05 was considered as statistically significant.
- Conditions
- Bone Injury
- Being tested
- Simvastatin 10mg
- Keywords
- Simvastatin, Salivary BMP-2, Radiographic Bone density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 10mgDrug
Also called SIM
Atraumatic Extraction and administration of SIM (10 mg tablet grounded and added with normal saline, with gelatin sponge as a transporter) into the socket to observe alveolar bone healing.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Atraumatic Extraction Only (placement of gelatin sponge mixed with normal saline without SIMVASTATIN). |
| Simvastatin | Experimental | Atraumatic Extraction and administration of SIMVASTATIN (10 mg tablet grounded and added with normal saline, with gelatin sponge as a transporter) into the socket. Receives: Drug: Simvastatin 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary BMP-2 Levels
Mean values were measured using ELISA technique
Measured: At start of study
Salivary BMP-2 Levels
Mean values were measured using ELISA technique
Measured: At 3rd day Of Study
Salivary BMP-2 Levels
Mean values were measured using ELISA technique
Measured: At 10th Day of study
Salivary BMP-2 Levels
Mean values were measured using ELISA technique
Measured: At 40th Day of study
Bone Density
Mean grey value were measured using imageJ software
Measured: At start of study
Bone Density
Mean grey value were measured using imageJ software
Measured: At 40th day of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start16 Dec 2020
- Primary completion3 Oct 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone InjuryStudies 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Medical Institute, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Mutahir Mehdi, Postgraduate Medical Institute, Lahore
- Investigators
- shagufta nasreen, Study chair, Pgmi. Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369091
- Sponsor's protocol ID
- M.Phil Oral Biology Trainee
- Acronym
- salivaryBMP2
- Status last verified
- May 2022
- First submitted
- 29 Mar 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Bmp-2 Levels And Radiographic Measurement Of Bone Density At Extracted Tooth Socket In Patients With And Without Topical Application Of Simvastatin
- ClinicalTrials.gov ID
- NCT05369091
- Acronym / sponsor ID
- salivaryBMP2 / M.Phil Oral Biology Trainee
- Conditions
- Bone Injury
- Keywords
- Simvastatin, Salivary BMP-2, Radiographic Bone density
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Postgraduate Medical Institute, LahoreUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 3 Oct 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 11 May 2022 (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.
Salivary Bmp-2 Levels \& Radiographic Measurement Of Bone Density were evaluated At Extracted Tooth Socket in patients With \& Without topical Application Of Simvastatin
Detailed description
Objective: The objective of this study was to compare:
'The salivary BMP-2 levels in the experimental and the control groups with and without topical simvastatin application on wound of extracted tooth socket.
The bone density at extracted tooth socket by measuring mean gray value from Intra oral periapical (IOPA) radiographs in the experimental and the control groups.
Method: Twenty four patients either male or female without any systemic disease, aged between 18 years to 25 years were selected. The patients were equally divided by random computer generated numbers into experimental and control groups. In the experimental group, tooth extraction was followed by placement of simvastatin (containing 10 mg of drug). In the control group, only tooth extraction was done. Saliva sample was collected from patients on days 0, 3, 7 and 40 and levels of salivary biomarker BMP-2 were measured with the ELISA technique. IOPA radiographs were taken on days 0 and 40 to determine the bone density by measuring mean gray values with the help of ImageJ software. The data was entered in SPSS version 25 and analyzed. P-value of ≤ 0.05 was considered as statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –Atraumatic Extraction Only (placement of gelatin sponge mixed with normal saline without SIMVASTATIN). |
| Simvastatin | Experimental | Drug: Simvastatin 10mgAtraumatic Extraction and administration of SIMVASTATIN (10 mg tablet grounded and added with normal saline, with gelatin sponge as a transporter) into the socket. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both male and female patients with permanent dentition, age (18 years to 25 years) were considered.
- Patients undergoing extraction of maxillary or mandibular Pre molars for orthodontic procedure.
- Teeth which required only simple non surgical extraction only under local anesthesia.
Key exclusion criteria (11 listed)
- Subjects taking antibiotics or non-steroidal anti inflammatory drugs (NSAIDS) within one week.
- Patients with oral mucosal lesions (leukoplakia, erythroplakia, lichen planus).
- Patients with oral carcinoma.
- Patients with xerostomia.
- Previous history of radiotherapy or chemotherapy
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 |
|---|---|---|
| Simvastatin 10mgAlso: SIMAtraumatic Extraction and administration of SIM (10 mg tablet grounded and added with normal saline, with gelatin sponge as a transporter) into the socket to observe alveolar bone healing. | Drug | Simvastatin |
Primary outcome
Salivary BMP-2 Levels
Time frame: At start of study
Mean values were measured using ELISA technique
Salivary BMP-2 Levels
Time frame: At 3rd day Of Study
Mean values were measured using ELISA technique
Salivary BMP-2 Levels
Time frame: At 10th Day of study
Mean values were measured using ELISA technique
Salivary BMP-2 Levels
Time frame: At 40th Day of study
Mean values were measured using ELISA technique
Bone Density
Time frame: At start of study
Mean grey value were measured using imageJ software
Bone Density
Time frame: At 40th day of study
Mean grey value were measured using imageJ software
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 11 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
shagufta nasreen study chair
Pgmi. Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin 10mg in people with Bone Injury, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
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 3 inclusion and 11 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 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Salivary BMP-2 Levels (time frame: At start of study). The study lists 6 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 11 May 2022.