Peridontal DiseasePRP-IPRFNCT06685393
Efficacy of Injectable Platelet-rich Fibrin Versus Platelet-Rich Plasma As Adjunctive to Scaling and Root Planning in Non-surgical Periodontal Therapy of Periodontitis Patients
A study testing Platelet rich plasma (PRP) and INJECTABLE PLATELET RICH FIBRIN(I-PRF) in people with Peridontal Disease, run by ELsabbahy Ahmed Mohamed Youssef at 1 site in Egypt.
Trial summary
The study aims to evaluate the Efficacy of Injectable Platelet-rich Fibrin versus Platelet-Rich Plasma as adjunctive to scaling and root planning in non-surgical periodontal therapy of Periodontitis patients (Randomized controlled clinical trial) Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Peridontal Disease
- What is being tested?
- Platelet rich plasma (PRP) and INJECTABLE PLATELET RICH FIBRIN(I-PRF)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2023to 25 Mar 2024
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Participants: Adult healthy individuals between 25-45 years old with no gender predilection diagnosed with periodontitis.
- Fasting blood sugar (80-100mg/dl): This is the recommended range for non-diabetic patients and is according to the American Diabetes Association.
- (Hemoglobin A1C (HbA1c) levels recommended by the American Diabetes Association. Patients with an HbA1c level equal to or less than 7% were considered patients with well-controlled DM.
- Patients with at least two quadrants with pocket depth up to 5 mm.
Who cannot join
- history of any preceding oral infections or periodontal treatment for at least three months before starting the study.
- Smokers and alcoholic patients
- pregnant, post-menopausal, and lactating women.
- Patients with poor systemic health like uncontrolled diabetes, hypertension, osteoporosis, and collagen disorders are also excluded with
- patients who were on or expected to take antibiotics or anti-inflammatory drugs within the duration of the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia, Egypt, 35516
About this study
Official title: Effects of Injectable Platelet-rich Fibrin and Platelet-Rich Plasma in Treatment of Diabetic Patients with Stage Ⅱ Grade C Periodontitis (Clinical and Microbiological Study).
The study aims to evaluate the Efficacy of Injectable Platelet-rich Fibrin versus Platelet-Rich Plasma as adjunctive to scaling and root planning in non-surgical periodontal therapy of Periodontitis patients (Randomized controlled clinical trial)
Read the detailed description
Mechanical Debridement (MD) is the gold standard procedure for managing periodontal diseases and infection control. Currently, a minimally invasive approach involving using of local platelets concentrates in the treatment of periodontitis, Platelets are nonnuclear secretory cells deduced from bone marrow as protein-producing cells. Upon activation, the platelets produce secretory grains and synthesize proteins. Platelets contain a variety of protein molecules ranging from membrane proteins, cytokines, regulatory proteins, and bioactive peptides.
Platelet-rich plasma (PRP) Is a 1st-generation platelet concentrate containing a high attention of platelet but a minimal amount of natural fibrinogen. The α granules release growth factors in 3-5 days of platelet activation, which sustain their stimulation of the proliferative phase for ten days after release.
Platelet-rich fibrin (PRF) is a second-generation platelet concentrate that was introduced by Choukroun et al. in 2001, It is allowed that PRF can improve tissue regeneration due to its effects on vascularization, capturing the circulating stem cells, immune control, and closure of the epithelium, Injectable PRF (I-PRF) is the liquid form of PRF. I-PRF is a bioactive agent attained by low-speed centrifugation, and it can stimulate tissue regeneration. I-PRF at high concentrations may stimulate the secretion of several growth factors and trigger fibroblast migration. I-PRF is generally used in regenerative treatments, but it has good issues.
Platelet concentrates (PCs) are characterized by an increased level of platelets, which are considered cells with a multifunctional role in antimicrobial host defense. First, platelets give a rapid response to microbial colonization of vascular endothelium and are the earliest cells at the affected site. Platelets can incorporate microbes themselves and perform pathogen clearance, killing or damaging microorganisms.
- Conditions
- Peridontal Disease
- Being tested
- Platelet rich plasma (PRP), INJECTABLE PLATELET RICH FIBRIN(I-PRF)
- Keywords
- periodontitis, PRP, I-PRF
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma (PRP)Procedure or surgery
At the 1st visit, each quadrant is scaled and root planned using an ultrasonic scaler and manual instruments until tactile sensation detects smooth crown and root surfaces these procedures were repeated on both sides starting from 1st visit of treatment,2nd,4th, and 6th-week intervals local anesthetic was utilized in some instances where it was the necessary and subgingival application of (PRP) at test side only at baseline,3ed, 6th week.
INJECTABLE PLATELET RICH FIBRIN(I-PRF)Procedure or surgery
At the 1st visit, each quadrant is scaled and root planned using an ultrasonic scaler and manual instruments until tactile sensation detects smooth crown and root surfaces these procedures were repeated on both sides starting from 1st visit of treatment,2nd,4th, and 6th-week intervals local anesthetic was utilized in some instances where it was the necessary and subgingival application of (I-PRF) at test side only at baseline,3ed, 6th week.
| Study group | Role | What they receive |
|---|---|---|
| Group (I) (nondiabetic PRPgroup) | Active comparator | Group (Ⅰ) (non-diabetic patients): n=10 subdivided into Test side: received scaling and rootplanning plus the subgingival application of PRP.
Control side: received scaling and rootplanning only. Receives: Procedure: Platelet rich plasma (PRP) |
| Group (Ⅱ) (non-diabetic patients): | Active comparator | Group (Ⅱ) (non-diabetic patients): n=10 subdivided into Test side: received MD plus subgingival application of I-PRF. Control side: received MD only. Receives: Procedure: INJECTABLE PLATELET RICH FIBRIN(I-PRF) |
| Group (Ⅲ) (diabetic patients) | Active comparator | Group (Ⅲ) (diabetic patients): n=10 subdivided into Test side: received MD plus subgingival application of PRP. Control side: received MD only. Receives: Procedure: Platelet rich plasma (PRP) |
| Group(Ⅳ) (diabetic patients) | Active comparator | Group(Ⅳ) (diabetic patients): n=10 subdivided into Test side: received MD plus the subgingival application of I-PRF Control side: received MD only. Receives: Procedure: INJECTABLE PLATELET RICH FIBRIN(I-PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical measurement of plaque index (PI).
It assesses oral hygiene and is based on the recording of soft debris on the teeth, plaque was scored using the plaque indices the Tarski et al Modified Quigley Hein Plaque Index (TQHPI). With the TQHPI, mesial, distal, and mid surfaces of facial and lingual aspects were scored:
0 = no plaque/debris
- = separate flecks of plaque at the cervical margin of the tooth.
- = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.
- = a band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth.
- = plaque covering at least one-third but less than two-thirds of the crown of the tooth.
- = plaque covering two-thirds or more of the crown of the tooth. The index for the tooth was calculated by adding the scores from the six surfaces of the tooth and dividing them by six. For each patient, a plaque index was calculated by adding up the indices for each of the teeth examined and dividing by the number of these teeth.
Measured: 3 months
clinical measurement of sulcular bleeding index (SBI).
In 1971, Muhlemann \& Son introduced the SBI, which was defined as follows:
Score 0 gingiva of normal texture and color, no bleeding. Score 1: gingiva normal, bleeding on probing. Score 2: bleeding on probing, change in color, no edema. Score 3: bleeding on probing change in color, slight oedema. Score 4: either: (a) bleeding on probing, change in color, obvious edema or (b) bleeding on probing, obvious edema.
Score 5: bleeding on probing and spontaneous bleeding, change in color, marked edema.
Measured: 3 months
clinical measurement of Probing depth (PD).
For all groups, the pocket depth measurement was calculated from the gingival margin to the base of the pocket in each quadrant between the first premolar and 1ST molar. It was taken at 6 locations which were mesiofacial, midfacial, distofacial, mesiolingual, midlingual, and distolingual.
To the closest millimeter, the standard William's graded probe was employed. It was inserted parallel to the tooth's long axis with light force; if present, any heavy calculus deposits interfering with measurement were removed.
The measurements were put together before being divided by six to determine the mean value of every tooth.
Following that, the pocket depth value for each patient was calculated by summing the values of all teeth, and then the total number of teeth tested divided by the sum.
Measured: 3 months
clinical measurement of Clinical attachment level (CAL).
For all groups, in each quadrant CAL is measured from the first premolar to the 2nd molar(in mm). By recording six values for every tooth and dividing them by six, the mean value for each tooth was determined. Then, by dividing the total number of teeth inspected by the sum of teeth, we got the mean value of CAL for each patient. If the CEJ landmark is missing because it has been destroyed by dental caries or has been removed by placement of a dental restoration, another fixed reference point can be used to measure attachment loss. Such landmarks might include the apical margin of a restoration or the incisal edge of a tooth. When attachment loss measurements are taken from a fixed landmark other than the CEJ they are called relative attachment loss measurements. Clinical attachment loss or relative attachment loss measurements are the best way to assess the presence or absence of additional periodontal damage
Measured: 3 months
Secondary outcomes (1)
MICROBIOLOGICAL PARAMETERS
Both periodontal pathogens Porphyromonas gingivalis (Pg) and Prevotella intermedia (PI) were detected within subgingival dental plaque samples at baseline before treatment, 6th, and 12th weeks by semiquantitative culture technique, and the resulting bacteria were identified using (PCR).• Quantification of each organism was done by counting the number of colonies forming units (CFU) on each plate. Because dilutions are based on 1 paper point, the plate count times the dilution factor yielded the total number of organisms per paper point A significant reduction was considered when the CFU/paper point decreased to ≤103; a non-significant reduction was considered when the CFU/paper point was 103-105; and a failure of treatment was considered when the CFU/paper point remained ≥105.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start5 Jan 2023
- Primary completion20 Dec 2023
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peridontal DiseaseStudies 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, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ELsabbahy Ahmed Mohamed Youssef
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ELsabbahy Ahmed Mohamed Youssef, Mansoura University
- Investigators
- Elsabbahy Ahmed Mohamed youssef, B.D.S, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685393
- Sponsor's protocol ID
- A11060722
- Acronym
- PRP-IPRF
- Status last verified
- Oct 2024
- First submitted
- 6 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Injectable Platelet-rich Fibrin and Platelet-Rich Plasma in Treatment of Diabetic Patients with Stage Ⅱ Grade C Periodontitis (Clinical and Microbiological Study).
- ClinicalTrials.gov ID
- NCT06685393
- Acronym / sponsor ID
- PRP-IPRF / A11060722
- Conditions
- Peridontal Disease
- Keywords
- periodontitis, PRP, I-PRF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ELsabbahy Ahmed Mohamed YoussefUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 12 Nov 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 study aims to evaluate the Efficacy of Injectable Platelet-rich Fibrin versus Platelet-Rich Plasma as adjunctive to scaling and root planning in non-surgical periodontal therapy of Periodontitis patients (Randomized controlled clinical trial)
Detailed description
Mechanical Debridement (MD) is the gold standard procedure for managing periodontal diseases and infection control. Currently, a minimally invasive approach involving using of local platelets concentrates in the treatment of periodontitis, Platelets are nonnuclear secretory cells deduced from bone marrow as protein-producing cells. Upon activation, the platelets produce secretory grains and synthesize proteins. Platelets contain a variety of protein molecules ranging from membrane proteins, cytokines, regulatory proteins, and bioactive peptides.
Platelet-rich plasma (PRP) Is a 1st-generation platelet concentrate containing a high attention of platelet but a minimal amount of natural fibrinogen. The α granules release growth factors in 3-5 days of platelet activation, which sustain their stimulation of the proliferative phase for ten days after release.
Platelet-rich fibrin (PRF) is a second-generation platelet concentrate that was introduced by Choukroun et al. in 2001, It is allowed that PRF can improve tissue regeneration due to its effects on vascularization, capturing the circulating stem cells, immune control, and closure of the epithelium, Injectable PRF (I-PRF) is the liquid form of PRF. I-PRF is a bioactive agent attained by low-speed centrifugation, and it can stimulate tissue regeneration. I-PRF at high concentrations may stimulate the secretion of several growth factors and trigger fibroblast migration. I-PRF is generally used in regenerative treatments, but it has good issues.
Platelet concentrates (PCs) are characterized by an increased level of platelets, which are considered cells with a multifunctional role in antimicrobial host defense. First, platelets give a rapid response to microbial colonization of vascular endothelium and are the earliest cells at the affected site. Platelets can incorporate microbes themselves and perform pathogen clearance, killing or damaging microorganisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group (I) (nondiabetic PRPgroup) | Active comparator | Procedure: Platelet rich plasma (PRP)Group (Ⅰ) (non-diabetic patients): n=10 subdivided into Test side: received scaling and rootplanning plus the subgingival application of PRP. Control side: received scaling and rootplanning only. |
| Group (Ⅱ) (non-diabetic patients): | Active comparator | Procedure: INJECTABLE PLATELET RICH FIBRIN(I-PRF)Group (Ⅱ) (non-diabetic patients): n=10 subdivided into Test side: received MD plus subgingival application of I-PRF. Control side: received MD only. |
| Group (Ⅲ) (diabetic patients) | Active comparator | Procedure: Platelet rich plasma (PRP)Group (Ⅲ) (diabetic patients): n=10 subdivided into Test side: received MD plus subgingival application of PRP. Control side: received MD only. |
| Group(Ⅳ) (diabetic patients) | Active comparator | Procedure: INJECTABLE PLATELET RICH FIBRIN(I-PRF)Group(Ⅳ) (diabetic patients): n=10 subdivided into Test side: received MD plus the subgingival application of I-PRF Control side: received MD only. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Participants: Adult healthy individuals between 25-45 years old with no gender predilection diagnosed with periodontitis.
Key exclusion criteria (5 listed)
- history of any preceding oral infections or periodontal treatment for at least three months before starting the study.
- Smokers and alcoholic patients
- pregnant, post-menopausal, and lactating women.
- Patients with poor systemic health like uncontrolled diabetes, hypertension, osteoporosis, and collagen disorders are also excluded with
- patients who were on or expected to take antibiotics or anti-inflammatory drugs within the duration of 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 |
|---|---|---|
| Platelet rich plasma (PRP)At the 1st visit, each quadrant is scaled and root planned using an ultrasonic scaler and manual instruments until tactile sensation detects smooth crown and root surfaces these procedures were repeated on both sides starting from 1st visit of treatment,2nd,4th, and 6th-week intervals local anesthetic was utilized in some instances where it was the necessary and subgingival application of (PRP) at test side only at baseline,3ed, 6th week. | Procedure or surgery | Group (I) (nondiabetic PRPgroup), Group (Ⅲ) (diabetic patients) |
| INJECTABLE PLATELET RICH FIBRIN(I-PRF)At the 1st visit, each quadrant is scaled and root planned using an ultrasonic scaler and manual instruments until tactile sensation detects smooth crown and root surfaces these procedures were repeated on both sides starting from 1st visit of treatment,2nd,4th, and 6th-week intervals local anesthetic was utilized in some instances where it was the necessary and subgingival application of (I-PRF) at test side only at baseline,3ed, 6th week. | Procedure or surgery | Group (Ⅱ) (non-diabetic patients):, Group(Ⅳ) (diabetic patients) |
Primary outcome
clinical measurement of plaque index (PI).
Time frame: 3 months
It assesses oral hygiene and is based on the recording of soft debris on the teeth, plaque was scored using the plaque indices the Tarski et al Modified Quigley Hein Plaque Index (TQHPI). With the TQHPI, mesial, distal, and mid surfaces of facial and lingual aspects were scored: 0 = no plaque/debris 1. = separate flecks of plaque at the cervical margin of the tooth. 2. = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth. 3. = a band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth. 4. = plaque covering at least one-third but less than two-thirds of the crown of the tooth. 5. = plaque covering two-thirds or more of the crown of the tooth. The index for the tooth was calculated by adding the scores from the six surfaces of the tooth and dividing them by six. For each patient, a plaque index was calculated by adding up the indices for each of the teeth examined and dividing by the number of these teeth.
clinical measurement of sulcular bleeding index (SBI).
Time frame: 3 months
In 1971, Muhlemann \& Son introduced the SBI, which was defined as follows: Score 0 gingiva of normal texture and color, no bleeding. Score 1: gingiva normal, bleeding on probing. Score 2: bleeding on probing, change in color, no edema. Score 3: bleeding on probing change in color, slight oedema. Score 4: either: (a) bleeding on probing, change in color, obvious edema or (b) bleeding on probing, obvious edema. Score 5: bleeding on probing and spontaneous bleeding, change in color, marked edema.
clinical measurement of Probing depth (PD).
Time frame: 3 months
For all groups, the pocket depth measurement was calculated from the gingival margin to the base of the pocket in each quadrant between the first premolar and 1ST molar. It was taken at 6 locations which were mesiofacial, midfacial, distofacial, mesiolingual, midlingual, and distolingual. To the closest millimeter, the standard William's graded probe was employed. It was inserted parallel to the tooth's long axis with light force; if present, any heavy calculus deposits interfering with measurement were removed. The measurements were put together before being divided by six to determine the mean value of every tooth. Following that, the pocket depth value for each patient was calculated by summing the values of all teeth, and then the total number of teeth tested divided by the sum.
clinical measurement of Clinical attachment level (CAL).
Time frame: 3 months
For all groups, in each quadrant CAL is measured from the first premolar to the 2nd molar(in mm). By recording six values for every tooth and dividing them by six, the mean value for each tooth was determined. Then, by dividing the total number of teeth inspected by the sum of teeth, we got the mean value of CAL for each patient. If the CEJ landmark is missing because it has been destroyed by dental caries or has been removed by placement of a dental restoration, another fixed reference point can be used to measure attachment loss. Such landmarks might include the apical margin of a restoration or the incisal edge of a tooth. When attachment loss measurements are taken from a fixed landmark other than the CEJ they are called relative attachment loss measurements. Clinical attachment loss or relative attachment loss measurements are the best way to assess the presence or absence of additional periodontal damage
1 secondary outcome
MICROBIOLOGICAL PARAMETERS
Time frame: 3 months
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 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Peridontal Disease
Not yet recruitingObservational study
Assessment of Peridontal Inflamatuar Markers in MIH
Molar-Incisor Hypomineralization (MIH)
RecruitingObservational study
Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid
Pemphigoid, Benign Mucous Membrane, Gingivitis Hyperplastic
RecruitingPhase 3
Efficacy of Resveratrol Containing Mouthwash in Reducing Halitosis Related Porphyrymonas Gingivalis.
Halitosis, Mouth Disease
Recruiting
The Effect of Hypnosis on Periodontal Treatment
Peridontal Disease, Dental Anxiety
Recruiting
Assessment of Pro-Resolution Mediator Levels in Periodontitis Stage III and IV Before and After Periodontal Therapy
Peridontal Disease
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.
Elsabbahy Ahmed Mohamed youssef, B.D.S principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma (PRP) and INJECTABLE PLATELET RICH FIBRIN(I-PRF) in people with Peridontal Disease, run by ELsabbahy Ahmed Mohamed Youssef at 1 site in Egypt.
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 4 inclusion and 5 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 12 Nov 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 Egypt. 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?
clinical measurement of plaque index (PI). (time frame: 3 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?
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 12 Nov 2024.