Alveolar Bone LossNCT04650763
Bone Healing in Immediate Dental Implants
A study testing PRP injection and Automated blood cell separator to extract PRP in people with Alveolar Bone Loss and Platelet Rich Plasma, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
Trial summary
To study the effect of platelet-rich plasma concentrate on marginal bone loss and bone mineral density in immediate implant placement through CBCT. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Platelet Rich Plasma
- What is being tested?
- PRP injection and Automated blood cell separator to extract PRP
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Oct 2017to 30 Mar 2018
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients maintaining good oral hygiene, having adequate bone quantity at the implant site, uneventful extraction
Who cannot join
- Active infection around implant site, immunocompromised state, with current major systemic disease (uncontrolled diabetes, rheumatoid arthritis, etc.) or oral pathologies, history of bleeding disorders or on anticoagulant therapy, or patients on bisphosphonates were excluded from the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of Dentistry; CMH Lahore Medical College
Lahore, Punjab Province
About this study
Official title: Effect of PRP on Bone Healing in Immediate Implants Analyzed by CBCT
To study the effect of platelet-rich plasma concentrate on marginal bone loss and bone mineral density in immediate implant placement through CBCT.
Read the detailed description
12 subjects were equally categorized into two groups. Group, I was the control group; whereas, the subjects in Group II received Platelet Rich Plasma (PRP) therapy. All subjects were given a standard treatment with single implant system. Inserted implants were analyzed through Cone Beam Computerized Tomography (CBCT). Records were registered at the baseline, at 12th week before functional loading and 26th week after functional loading.
- Conditions
- Alveolar Bone Loss, Platelet Rich Plasma
- Being tested
- PRP injection, Automated blood cell separator to extract PRP
- Keywords
- Dental implant, Cone Beam Computerized Tomography (CBCT).
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionBiological
Also called Platelet Rich Plasma injection
PRP was prepared using patient's blood and mixed with saline or mixture of calcium chloride and thrombin to form a liquid solution; in order to inject at the surgical site after placement of implant.
Automated blood cell separator to extract PRPDevice
Also called Automated blood cell separator/ centrifuge
Blood was withdrawn from antecubital vein and mixed with anticoagulant. Blood sample was then centrifuged to obtain platelet rich plasma which was injected at surgical site after implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Dental implant was placed in these patients following full protocol of immediate implant placement. |
| PRP Group | Experimental | In this group Platelet Rich Plasma (PRP) was injected in soft tissue over surgical site. Receives: Biological: PRP injection; Device: Automated blood cell separator to extract PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of bone loss at baseline (12 weeks) and later at 26weeks
Measurement at mesial in mm
Measured: Baseline -before functional loading at 12 weeks & at 26 weeks- after functional loading to assess changes in marginal bone loss in sagittal view using CBCT
Secondary outcomes (1)
Measurement of bone loss at baseline (12 weeks) and later at 26weeks
Measurement at distal in mm
Measured: Baseline -before functional loading at 12 weeks & at 26 weeks- after functional loading to assess changes in marginal bone loss in sagittal view using CBCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start2 Oct 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Lahore Medical College and Institute of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Abdul Mueed Zaigham, CMH Lahore Medical College and Institute of Dentistry
- Investigators
- Aleshba Saba khan, BDS; FCPS, Principal investigator, Institute of Dentistry; CMH Lahore Medical CollegeNaauman Zaheer, BDS; PhD, Principal investigator, Institute of Dentistry; CMH Lahore Medical CollegeAbdul Mueed Zaigham, BDS; FCPS, Study chair, Institute of Dentistry; CMH Lahore Medical CollegeMaliha Shahbaz, BDS; MPhil, Study director, Oral Biology Department; Rashid Latif Dental College, LahoreUsman Zaheer, BDS; FCPS, Principal investigator, Lahore Medical & Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650763
- Sponsor's protocol ID
- Case # 466/ERC/CMH/LMC
- Status last verified
- Nov 2020
- First submitted
- 14 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Boora P, Rathee M, Bhoria M. Effect of Platelet Rich Fibrin (PRF) on Peri-implant Soft Tissue and Crestal Bone in One-Stage Implant Placement: A Randomized Controlled Trial. J Clin Diagn Res. 2015 Apr;9(4):ZC18-21. doi: 10.7860/JCDR/2015/12636.5788. Epub 2015 Apr 1.
PubMed 26023636Khan AS, Zaheer N, Zaigham AM, Shahbaz M, Zaheer U, Alam MK. Effect of Platelet-Rich Plasma on Bone Healing in Immediate Implants Analyzed by Cone Beam Computerized Tomography: A Randomized Controlled Trial. Biomed Res Int. 2021 Mar 13;2021:6685991. doi: 10.1155/2021/6685991. eCollection 2021.
PubMed 33791377
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PRP on Bone Healing in Immediate Implants Analyzed by CBCT
- ClinicalTrials.gov ID
- NCT04650763
- Acronym / sponsor ID
- Case # 466/ERC/CMH/LMC
- Conditions
- Alveolar Bone Loss, Platelet Rich Plasma
- Keywords
- Dental implant, Cone Beam Computerized Tomography (CBCT).
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CMH Lahore Medical College and Institute of DentistryUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 3 Dec 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.
To study the effect of platelet-rich plasma concentrate on marginal bone loss and bone mineral density in immediate implant placement through CBCT.
Detailed description
12 subjects were equally categorized into two groups. Group, I was the control group; whereas, the subjects in Group II received Platelet Rich Plasma (PRP) therapy. All subjects were given a standard treatment with single implant system. Inserted implants were analyzed through Cone Beam Computerized Tomography (CBCT). Records were registered at the baseline, at 12th week before functional loading and 26th week after functional loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Dental implant was placed in these patients following full protocol of immediate implant placement. |
| PRP Group | Experimental | Biological: PRP injection, Device: Automated blood cell separator to extract PRPIn this group Platelet Rich Plasma (PRP) was injected in soft tissue over surgical site. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients maintaining good oral hygiene, having adequate bone quantity at the implant site, uneventful extraction
Key exclusion criteria (1 listed)
- Active infection around implant site, immunocompromised state, with current major systemic disease (uncontrolled diabetes, rheumatoid arthritis, etc.) or oral pathologies, history of bleeding disorders or on anticoagulant therapy, or patients on bisphosphonates were excluded from the study
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 |
|---|---|---|
| PRP injectionAlso: Platelet Rich Plasma injectionPRP was prepared using patient's blood and mixed with saline or mixture of calcium chloride and thrombin to form a liquid solution; in order to inject at the surgical site after placement of implant. | Biological | PRP Group |
| Automated blood cell separator to extract PRPAlso: Automated blood cell separator/ centrifugeBlood was withdrawn from antecubital vein and mixed with anticoagulant. Blood sample was then centrifuged to obtain platelet rich plasma which was injected at surgical site after implant placement. | Device | PRP Group |
Primary outcome
Measurement of bone loss at baseline (12 weeks) and later at 26weeks
Time frame: Baseline -before functional loading at 12 weeks & at 26 weeks- after functional loading to assess changes in marginal bone loss in sagittal view using CBCT
Measurement at mesial in mm
1 secondary outcome
Measurement of bone loss at baseline (12 weeks) and later at 26weeks
Time frame: Baseline -before functional loading at 12 weeks & at 26 weeks- after functional loading to assess changes in marginal bone loss in sagittal view using CBCT
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 3 Dec 2020.
- Results publication: PubMed 26023636Boora P, Rathee M, Bhoria M. Effect of Platelet Rich Fibrin (PRF) on Peri-implant Soft Tissue and Crestal Bone in One-Stage Implant Placement: A Randomized Controlled Trial. J Clin Diagn Res. 2015 Apr;9(4):ZC18-21. doi: 10.7860/JCDR/2015/12636.5788. Epub 2015 Apr 1.
- Derived from this study: PubMed 33791377Khan AS, Zaheer N, Zaigham AM, Shahbaz M, Zaheer U, Alam MK. Effect of Platelet-Rich Plasma on Bone Healing in Immediate Implants Analyzed by Cone Beam Computerized Tomography: A Randomized Controlled Trial. Biomed Res Int. 2021 Mar 13;2021:6685991. doi: 10.1155/2021/6685991. eCollection 2021.
- Individual participant dataSharing planned: No
Related trials for Alveolar Bone Loss
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Recruiting
Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
Dental Implant, Immediate Dental Implant Placement
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
Recruiting
Bone Marrow Mononuclear Cells for the Repair of Severe Maxillofacial Bone Defects
Maxillofacial Bone Defect, Alveolar Bone Loss
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.
Aleshba Saba khan, BDS; FCPS principal investigator
Institute of Dentistry; CMH Lahore Medical College
Naauman Zaheer, BDS; PhD principal investigator
Institute of Dentistry; CMH Lahore Medical College
Abdul Mueed Zaigham, BDS; FCPS study chair
Institute of Dentistry; CMH Lahore Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection and Automated blood cell separator to extract PRP in people with Alveolar Bone Loss and Platelet Rich Plasma, run by CMH Lahore Medical College and Institute of Dentistry 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 1 inclusion and 1 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 3 Dec 2020. 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.
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?
Measurement of bone loss at baseline (12 weeks) and later at 26weeks (time frame: Baseline -before functional loading at 12 weeks & at 26 weeks- after functional loading to assess changes in marginal bone loss in sagittal view using CBCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650763, which also lists 2 linked publications.
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 3 Dec 2020.