Dental ImplantsNCT06525324
Comparision of Clinical Efficacy of Immediate Implants With T-PRF and Bone-graft Versus PRF and Bone-graft
A study testing Immediate implant surgery with T-PRF and xenograft and Immediate implant surgery with PRF and xenograft in people with Dental Implants, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The normal architecture of the alveolar process is altered by periodontitis, which also causes the loss of alveolar bone surrounding the teeth. Untreated periodontitis may cause teeth to become mobile and leads to loss of teeth. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Immediate implant surgery with T-PRF and xenograft and Immediate implant surgery with PRF and xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2024to Oct 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 18-55 years of age.
- Presence of non-restorable teeth (maxillary or mandibular) due to trauma, decayed, mobility, root resorption, root stumps, root fracture, over retained deciduous tooth, endodontic or periodontal failure in whom immediate implants can be placed.
- Good oral hygiene.
- Good patient compliance.
- Class I extraction socket defects according to modified Elian et al 2021.
Who cannot join
- Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases).
- Intravenous and oral bisphosphonate therapy.
- Patients who are psychologically unable to participate.
- Pregnant and lactating participants with bone diseases
- Patients on chemotherapy or radiotherapy
- Alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
About this study
Official title: Comparing The Effectiveness Of T-PRF And PRF With Bone-Graft[DMBM]TM Around Immediate Implants - A RANDOMISED CONTROL TRIAL
The normal architecture of the alveolar process is altered by periodontitis, which also causes the loss of alveolar bone surrounding the teeth. Untreated periodontitis may cause teeth to become mobile and leads to loss of teeth.
In such cases, one of the treatment modalities is extraction of the tooth and placement of immediate implant which reduces the waiting period. And due to the resorption of alveolar ridge the bone graft will be used along with T-PRF and PRF.
So this study aims at the placement of immediate implants along with T-PRF with bone graft and PRF with bone graft.
Read the detailed description
Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. And their will be resorption of alveolar process due to periodontitis . In such compromised cases, to achieve bone augmentation around immediately placed implants a new modality of using platelet rich fibrin (PRF) along with graft material has gained considerable interest.
Successful clinical results have been reported with L-PRF, but some physicians worry about a possible health hazard with glass-evacuated blood collection tubes with silica activators. O'Connell described the unavoidable silica contact. The silica particles in the tube, although dense enough to sediment with the red blood cells, are small enough for a fraction to remain colloidally suspended in the buffy coat, fibrin, and platelet-poor plasma layers therefore, these particles might reach the patient when the product is used for treatment.
Recently use of titanium tubes in the preparation of PRF showed more polymerized fibrin formation with longer resorption in tissues as titanium seems to be more effective in activating platelets than silica and also eliminates the possible silica contamination.
The use of T-PRF(Titanium PRF) along with xenograft creates a block graft with high concentrated growth factors, platelets and leucocytes which enhance development of bone and eliminates the possible silica contamination.
Hence, the aim of the study is to compare the effectiveness of T-PRF with xenograft [DMBM] and PRF with xenograft [DMBM] around immediate implants.
- Conditions
- Dental Implants
- Being tested
- Immediate implant surgery with T-PRF and xenograft, Immediate implant surgery with PRF and xenograft
- Keywords
- PRF with bone graft, T-PRF with bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant surgery with T-PRF and xenograftProcedure or surgery
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with T-PRF and xenograft will be placed according to the standard protocol.
The surgical wound closure will be coapted with mattress and single interrupted sutures
Immediate implant surgery with PRF and xenograftProcedure or surgery
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with PRF and xenograft will be placed according to the standard protocol .
The surgical wound closure will be coapted with mattress and single interrupted sutures
| Study group | Role | What they receive |
|---|---|---|
| in 10 sites immediate implant will be placed along with T-PRF and xenograft | Experimental | Immediate implant is placed along with T-PRF and xenograft. Receives: Procedure: Immediate implant surgery with T-PRF and xenograft |
| in 10 sites immediate implants will be placed with PRF and xenograft | Active comparator | Immediate implant is placed along with PRF and xenograft as control Receives: Procedure: Immediate implant surgery with PRF and xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Level Using RVG and Grid.
Marginal bone level measured .
Measured: Baseline , 3 months , 9 months
Soft tissue healing
Soft tissue healing will be assessed using Wachtel-et-al 2009 classification
Measured: Baseline ,3 months , 9 months
Bone fill using RVG with grid
Measuring the Bone fill by formula Linear bone growth/depth of original bone defect
Measured: 3 months , 9 months
Bone dimensions using CBCT
Extent of bone dimensions is measured through CBCT
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525324
- Sponsor's protocol ID
- 02_D012_00041
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared with other researchers.
Publications
Tunali M, Ozdemir H, Kucukodaci Z, Akman S, Firatli E. In vivo evaluation of titanium-prepared platelet-rich fibrin (T-PRF): a new platelet concentrate. Br J Oral Maxillofac Surg. 2013 Jul;51(5):438-43. doi: 10.1016/j.bjoms.2012.08.003. Epub 2012 Aug 28.
PubMed 22951383
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing The Effectiveness Of T-PRF And PRF With Bone-Graft[DMBM]TM Around Immediate Implants - A RANDOMISED CONTROL TRIAL
- ClinicalTrials.gov ID
- NCT06525324
- Acronym / sponsor ID
- 02_D012_00041
- Conditions
- Dental Implants
- Keywords
- PRF with bone graft, T-PRF with bone graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 29 Jul 2024 (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.
The normal architecture of the alveolar process is altered by periodontitis, which also causes the loss of alveolar bone surrounding the teeth. Untreated periodontitis may cause teeth to become mobile and leads to loss of teeth.
In such cases, one of the treatment modalities is extraction of the tooth and placement of immediate implant which reduces the waiting period. And due to the resorption of alveolar ridge the bone graft will be used along with T-PRF and PRF.
So this study aims at the placement of immediate implants along with T-PRF with bone graft and PRF with bone graft.
Detailed description
Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. And their will be resorption of alveolar process due to periodontitis . In such compromised cases, to achieve bone augmentation around immediately placed implants a new modality of using platelet rich fibrin (PRF) along with graft material has gained considerable interest.
Successful clinical results have been reported with L-PRF, but some physicians worry about a possible health hazard with glass-evacuated blood collection tubes with silica activators. O'Connell described the unavoidable silica contact. The silica particles in the tube, although dense enough to sediment with the red blood cells, are small enough for a fraction to remain colloidally suspended in the buffy coat, fibrin, and platelet-poor plasma layers therefore, these particles might reach the patient when the product is used for treatment.
Recently use of titanium tubes in the preparation of PRF showed more polymerized fibrin formation with longer resorption in tissues as titanium seems to be more effective in activating platelets than silica and also eliminates the possible silica contamination.
The use of T-PRF(Titanium PRF) along with xenograft creates a block graft with high concentrated growth factors, platelets and leucocytes which enhance development of bone and eliminates the possible silica contamination.
Hence, the aim of the study is to compare the effectiveness of T-PRF with xenograft [DMBM] and PRF with xenograft [DMBM] around immediate implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in 10 sites immediate implant will be placed along with T-PRF and xenograft | Experimental | Procedure: Immediate implant surgery with T-PRF and xenograftImmediate implant is placed along with T-PRF and xenograft. |
| in 10 sites immediate implants will be placed with PRF and xenograft | Active comparator | Procedure: Immediate implant surgery with PRF and xenograftImmediate implant is placed along with PRF and xenograft as control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients between 18-55 years of age.
- Presence of non-restorable teeth (maxillary or mandibular) due to trauma, decayed, mobility, root resorption, root stumps, root fracture, over retained deciduous tooth, endodontic or periodontal failure in whom immediate implants can be placed.
- Good oral hygiene.
- Good patient compliance.
- Class I extraction socket defects according to modified Elian et al 2021.
Key exclusion criteria (6 listed)
- Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases).
- Intravenous and oral bisphosphonate therapy.
- Patients who are psychologically unable to participate.
- Pregnant and lactating participants with bone diseases
- Patients on chemotherapy or radiotherapy
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 |
|---|---|---|
| Immediate implant surgery with T-PRF and xenograftA mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with T-PRF and xenograft will be placed according to the standard protocol. The surgical wound closure will be coapted with mattress and single interrupted sutures | Procedure or surgery | in 10 sites immediate implant will be placed along with T-PRF and xenograft |
| Immediate implant surgery with PRF and xenograftA mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with PRF and xenograft will be placed according to the standard protocol . The surgical wound closure will be coapted with mattress and single interrupted sutures | Procedure or surgery | in 10 sites immediate implants will be placed with PRF and xenograft |
Primary outcome
Marginal Bone Level Using RVG and Grid.
Time frame: Baseline , 3 months , 9 months
Marginal bone level measured .
Soft tissue healing
Time frame: Baseline ,3 months , 9 months
Soft tissue healing will be assessed using Wachtel-et-al 2009 classification
Bone fill using RVG with grid
Time frame: 3 months , 9 months
Measuring the Bone fill by formula Linear bone growth/depth of original bone defect
Bone dimensions using CBCT
Time frame: 9 months
Extent of bone dimensions is measured through CBCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Background: PubMed 22951383Tunali M, Ozdemir H, Kucukodaci Z, Akman S, Firatli E. In vivo evaluation of titanium-prepared platelet-rich fibrin (T-PRF): a new platelet concentrate. Br J Oral Maxillofac Surg. 2013 Jul;51(5):438-43. doi: 10.1016/j.bjoms.2012.08.003. Epub 2012 Aug 28.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant surgery with T-PRF and xenograft and Immediate implant surgery with PRF and xenograft in people with Dental Implants, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
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 6 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: status not confirmed, as of the sponsor's last update on 29 Jul 2024. 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 India. 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?
Results are not available in the source record.
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?
Marginal Bone Level Using RVG and Grid. (time frame: Baseline , 3 months , 9 months). The study lists 4 primary outcomes in all. 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 NCT06525324, which also lists 1 linked publication.
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 29 Jul 2024.