PeriodontitisNCT07395726
Impact of Platelet-Rich Fibrin on Periodontal Tissue Regeneration
A study testing Open Flap Debridement and Platelet-Rich Fibrin with Open Flap Debridement in people with Periodontitis and Periodontal Intrabony Defects, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
The purpose of this research is to assess the efficacy of Platelet-Rich Fibrin (PRF) in the regeneration of periodontal tissues in patients suffering from periodontal disease. Periodontal disease is a chronic inflammatory disease that affects the gums and the bone supporting the teeth, which can eventually result in… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontitis, Periodontal Intrabony Defects
- What is being tested?
- Open Flap Debridement and Platelet-Rich Fibrin with Open Flap Debridement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 May 2025to 15 Nov 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-65 years. Diagnosed with chronic periodontitis according to standard clinical criteria. Presence of periodontal intrabony defects suitable for surgical intervention. Probing pocket depth (PPD) ≥ 5 mm at the target site. Clinical attachment level (CAL) loss ≥ 3 mm at the target site. Good oral hygiene, with full-mouth plaque score < 25%.
Who cannot join
- Patients with systemic diseases that affect healing (e.g., uncontrolled diabetes, immunodeficiency).
- Pregnant or lactating women. Current smokers or tobacco users. History of periodontal surgery at the target site within the last 12 months. Use of medications that interfere with wound healing (e.g., corticosteroids, bisphosphonates).
- Allergies or contraindications to local anesthetics or components used in the study.
- Active oral infections or untreated caries at or near the target site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Platelet-Rich Fibrin on Periodontal Tissue Regeneration: A Randomized Controlled Trial
The purpose of this research is to assess the efficacy of Platelet-Rich Fibrin (PRF) in the regeneration of periodontal tissues in patients suffering from periodontal disease. Periodontal disease is a chronic inflammatory disease that affects the gums and the bone supporting the teeth, which can eventually result in the loss of teeth if left untreated. Conventional periodontal treatment can control the infection and halt the progression of the disease but cannot reverse the loss of the supporting structures.
Platelet-Rich Fibrin is a biologic material derived from a small amount of the patient's own blood. It has growth factors that can potentially enhance healing and facilitate the regeneration of bone and soft tissues. In this randomized controlled clinical trial, patients will be randomly assigned to either conventional periodontal surgical treatment or conventional treatment along with PRF.
Over a predetermined follow-up period, clinical measurements like gum pocket depth, attachment levels, and radiographic bone changes will be assessed to see if PRF offers any extra advantages in tissue healing and regeneration. The results of this study could improve long-term oral health outcomes and periodontal disease treatment approaches.
Read the detailed description
Periodontal disease is marked by the inflammation-mediated loss of the supporting structures of the teeth, leading to the formation of periodontal pockets, loss of clinical attachment, and resorption of the alveolar bone. The regenerative aspect of periodontal therapy aims at the replacement of these lost structures to improve the stability of the teeth and their functional status in the oral environment. Platelet-Rich Fibrin (PRF), an autologous platelet concentrate derived from the centrifugation of the patient's blood, is a fibrin matrix rich in growth factors that could potentially improve wound healing, angiogenesis, and bone regeneration.
The aim of this randomized controlled clinical trial is to assess the additional role of PRF when used in combination with conventional periodontal surgical therapy compared to conventional therapy alone in patients diagnosed with periodontal defects that require surgical treatment. The participants will be randomly assigned into two groups. The control group will undergo conventional periodontal surgical therapy, while the intervention group will undergo the same surgical therapy plus PRF. The procedures will be carried out according to standardized clinical protocols to ensure uniformity among the participants.
The clinical outcomes will be measured by changes in pocket depth, clinical attachment level, and other periodontal parameters. Radiographic analysis will also be conducted to evaluate bone fill and regenerative outcomes at specific intervals. The safety of the procedure will be continuously monitored, and since the PRF is autologous, the risk of immunologic reaction is minimal.
This study will offer high-quality evidence on the effectiveness of PRF as a regenerative tool in periodontal therapy and may help in making better clinical decisions in the treatment of periodontal defects.
- Conditions
- Periodontitis, Periodontal Intrabony Defects
- Being tested
- Open Flap Debridement, Platelet-Rich Fibrin with Open Flap Debridement
- Keywords
- Platelet-Rich Fibrin, Periodontitis, Periodontal Regeneration, Probing Pocket Depth, Clinical Attachment Level
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Flap DebridementProcedure or surgery
Participants assigned to this arm will undergo conventional open flap debridement (OFD) for the treatment of periodontal intrabony defects. The procedure involves flap elevation, thorough debridement of granulation tissue, root surface instrumentation, defect decontamination, and flap repositioning with suturing. Standard postoperative care and oral hygiene instructions will be provided.
Platelet-Rich Fibrin with Open Flap DebridementProcedure or surgery
Participants assigned to this arm will receive autologous Platelet-Rich Fibrin (PRF) as an adjunct to conventional open flap debridement. PRF will be prepared from the participant's venous blood using centrifugation and placed directly into the periodontal defect prior to flap closure to promote tissue regeneration and enhance healing. All other surgical and postoperative procedures will be identical to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Open Flap Debridement | Placebo comparator | Participants assigned to this arm will undergo conventional open flap debridement (OFD) for the treatment of periodontal intrabony defects. The procedure involves flap elevation, thorough debridement of granulation tissue, root surface instrumentation, defect decontamination, and flap repositioning with suturing. Standard postoperative care and oral hygiene instructions will be provided. Receives: Procedure: Open Flap Debridement |
| Platelet-Rich Fibrin with Open Flap Debridement | Experimental | Participants assigned to this arm will receive autologous Platelet-Rich Fibrin (PRF) as an adjunct to conventional open flap debridement. PRF will be prepared from the participant's venous blood using centrifugation and placed directly into the periodontal defect prior to flap closure to promote tissue regeneration and enhance healing. All other surgical and postoperative procedures will be identical to the control group. Receives: Procedure: Platelet-Rich Fibrin with Open Flap Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
Probing pocket depth will be measured in millimeters using a calibrated periodontal probe at the selected defect sites. The outcome will be defined as the mean reduction in PPD from baseline to 6 months following surgery.
Measured: Baseline to 6 months postoperatively.
Secondary outcomes (2)
Change in Clinical Attachment Level (CAL)
Clinical attachment level will be assessed in millimeters using a standardized periodontal probe. The outcome will be defined as the mean gain in CAL from baseline to 6 months after treatment.
Measured: Baseline to 6 months postoperatively.
Percentage of Radiographic Bone Fill
Bone regeneration will be evaluated using cone-beam computed tomography (CBCT). The percentage of bone fill within the periodontal defect will be calculated by comparing baseline and 6-month radiographic measurements.
Measured: Baseline to 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start20 May 2025
- Primary completion25 Oct 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdullah, Armed Forces Institute of Dentistry, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395726
- Sponsor's protocol ID
- 21MDC1
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Many single-center clinical trials, especially in dentistry, do not share IPD publicly. Sharing IPD requires additional ethical approval, consent language, and data management plans.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Platelet-Rich Fibrin on Periodontal Tissue Regeneration: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07395726
- Acronym / sponsor ID
- 21MDC1
- Conditions
- Periodontitis, Periodontal Intrabony Defects
- Keywords
- Platelet-Rich Fibrin, Periodontitis, Periodontal Regeneration, Probing Pocket Depth, Clinical Attachment Level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 9 Feb 2026 (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 purpose of this research is to assess the efficacy of Platelet-Rich Fibrin (PRF) in the regeneration of periodontal tissues in patients suffering from periodontal disease. Periodontal disease is a chronic inflammatory disease that affects the gums and the bone supporting the teeth, which can eventually result in the loss of teeth if left untreated. Conventional periodontal treatment can control the infection and halt the progression of the disease but cannot reverse the loss of the supporting structures.
Platelet-Rich Fibrin is a biologic material derived from a small amount of the patient's own blood. It has growth factors that can potentially enhance healing and facilitate the regeneration of bone and soft tissues. In this randomized controlled clinical trial, patients will be randomly assigned to either conventional periodontal surgical treatment or conventional treatment along with PRF.
Over a predetermined follow-up period, clinical measurements like gum pocket depth, attachment levels, and radiographic bone changes will be assessed to see if PRF offers any extra advantages in tissue healing and regeneration. The results of this study could improve long-term oral health outcomes and periodontal disease treatment approaches.
Detailed description
Periodontal disease is marked by the inflammation-mediated loss of the supporting structures of the teeth, leading to the formation of periodontal pockets, loss of clinical attachment, and resorption of the alveolar bone. The regenerative aspect of periodontal therapy aims at the replacement of these lost structures to improve the stability of the teeth and their functional status in the oral environment. Platelet-Rich Fibrin (PRF), an autologous platelet concentrate derived from the centrifugation of the patient's blood, is a fibrin matrix rich in growth factors that could potentially improve wound healing, angiogenesis, and bone regeneration.
The aim of this randomized controlled clinical trial is to assess the additional role of PRF when used in combination with conventional periodontal surgical therapy compared to conventional therapy alone in patients diagnosed with periodontal defects that require surgical treatment. The participants will be randomly assigned into two groups. The control group will undergo conventional periodontal surgical therapy, while the intervention group will undergo the same surgical therapy plus PRF. The procedures will be carried out according to standardized clinical protocols to ensure uniformity among the participants.
The clinical outcomes will be measured by changes in pocket depth, clinical attachment level, and other periodontal parameters. Radiographic analysis will also be conducted to evaluate bone fill and regenerative outcomes at specific intervals. The safety of the procedure will be continuously monitored, and since the PRF is autologous, the risk of immunologic reaction is minimal.
This study will offer high-quality evidence on the effectiveness of PRF as a regenerative tool in periodontal therapy and may help in making better clinical decisions in the treatment of periodontal defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Flap Debridement | Placebo comparator | Procedure: Open Flap DebridementParticipants assigned to this arm will undergo conventional open flap debridement (OFD) for the treatment of periodontal intrabony defects. The procedure involves flap elevation, thorough debridement of granulation tissue, root surface instrumentation, defect decontamination, and flap repositioning with suturing. Standard postoperative care and oral hygiene instructions will be provided. |
| Platelet-Rich Fibrin with Open Flap Debridement | Experimental | Procedure: Platelet-Rich Fibrin with Open Flap DebridementParticipants assigned to this arm will receive autologous Platelet-Rich Fibrin (PRF) as an adjunct to conventional open flap debridement. PRF will be prepared from the participant's venous blood using centrifugation and placed directly into the periodontal defect prior to flap closure to promote tissue regeneration and enhance healing. All other surgical and postoperative procedures will be identical to the control group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged 18-65 years. Diagnosed with chronic periodontitis according to standard clinical criteria. Presence of periodontal intrabony defects suitable for surgical intervention. Probing pocket depth (PPD) ≥ 5 mm at the target site. Clinical attachment level (CAL) loss ≥ 3 mm at the target site. Good oral hygiene, with full-mouth plaque score < 25%.
Key exclusion criteria (4 listed)
- Patients with systemic diseases that affect healing (e.g., uncontrolled diabetes, immunodeficiency).
- Pregnant or lactating women. Current smokers or tobacco users. History of periodontal surgery at the target site within the last 12 months. Use of medications that interfere with wound healing (e.g., corticosteroids, bisphosphonates).
- Allergies or contraindications to local anesthetics or components used in the study.
- Active oral infections or untreated caries at or near the target site.
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 |
|---|---|---|
| Open Flap DebridementParticipants assigned to this arm will undergo conventional open flap debridement (OFD) for the treatment of periodontal intrabony defects. The procedure involves flap elevation, thorough debridement of granulation tissue, root surface instrumentation, defect decontamination, and flap repositioning with suturing. Standard postoperative care and oral hygiene instructions will be provided. | Procedure or surgery | Open Flap Debridement |
| Platelet-Rich Fibrin with Open Flap DebridementParticipants assigned to this arm will receive autologous Platelet-Rich Fibrin (PRF) as an adjunct to conventional open flap debridement. PRF will be prepared from the participant's venous blood using centrifugation and placed directly into the periodontal defect prior to flap closure to promote tissue regeneration and enhance healing. All other surgical and postoperative procedures will be identical to the control group. | Procedure or surgery | Platelet-Rich Fibrin with Open Flap Debridement |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: Baseline to 6 months postoperatively.
Probing pocket depth will be measured in millimeters using a calibrated periodontal probe at the selected defect sites. The outcome will be defined as the mean reduction in PPD from baseline to 6 months following surgery.
2 secondary outcomes
Change in Clinical Attachment Level (CAL)
Time frame: Baseline to 6 months postoperatively.
Percentage of Radiographic Bone Fill
Time frame: Baseline to 6 months postoperatively.
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 9 Feb 2026.
- Individual participant dataSharing planned: No. Many single-center clinical trials, especially in dentistry, do not share IPD publicly. Sharing IPD requires additional ethical approval, consent language, and data management plans.
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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 Open Flap Debridement and Platelet-Rich Fibrin with Open Flap Debridement in people with Periodontitis and Periodontal Intrabony Defects, run by Armed Forces Institute of Dentistry, Pakistan 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 4 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 9 Feb 2026. 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. 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.
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?
Change in Probing Pocket Depth (PPD) (time frame: Baseline to 6 months postoperatively.). 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 9 Feb 2026.