Dental ImplantNCT07033351
The Effect of Platelet Rich Fibrin Layers on Peri-implant Tissue Phenotype
A study testing Dental implant placement without PRF, Single-layer PRF membrane application and Triple-layer PRF membrane application in people with Dental Implant and Platelet Rich Fibrin, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
The present investigation seeks to determine how varying quantities of Platelet-Rich Fibrin (PRF) membranes influence the repair of both gingival and osseous tissues adjacent to dental implants. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Platelet Rich Fibrin, Keratinized Mucosa
- What is being tested?
- Dental implant placement without PRF, Single-layer PRF membrane application and Triple-layer PRF membrane application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2025to 6 Jun 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (male or female) over 18 years of age.
- Partially edentulous spaces.
- No history of bone augmentation procedures in the implant site.
- Good oral health, as measured by:
- Calibrated gingival bleeding index (≤10%)
- O'Leary plaque index (<10%)
Who cannot join
- Bleeding disorders.
- Compromised immune systems.
- Excessive smoking or alcohol consumption.
- Poor oral hygiene.
- Diabetes.
- Inability to attend follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
The present investigation seeks to determine how varying quantities of Platelet-Rich Fibrin (PRF) membranes influence the repair of both gingival and osseous tissues adjacent to dental implants. A secondary objective is to establish whether the incorporation of PRF contributes to enhanced stability of the soft-tissue cover and more effective retention of alveolar bone over an extended period.
Central to the study are two specific inquiries: Does the application of PRF correlate with an increase in the width and thickness of keratinized mucosa surrounding the implant? Is there a dose-response relationship such that the use of multiple PRF layers yields superior maintenance of bone height compared with a single layer or no PRF at all?
Read more
To address these questions, clinicians will juxtapose three treatment groups: one receiving no PRF, another receiving a single membrane, and a third receiving a triple-layer graft. Healing parameters will be measured before surgery and again at 6-week and 12-week checkpoints, allowing direct appraisal of outcome changes across the comparative cohorts.
Each participant will ultimately be allotted to one of the experimental arms by random assignment, thus mitigating selection bias. Routine follow-up examinations and radiographic imaging, will be used to track healing progress.
- Being tested
- Dental implant placement without PRF, Single-layer PRF membrane application, Triple-layer PRF membrane application
- Keywords
- Platelet-Rich Fibrin (PRF), Dental Implant, Keratinized Mucosa, Crestal Bone Level, Soft Tissue Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placement without PRFProcedure or surgery
Standard dental implant placement procedure with flap elevation and suturing, without the application of any PRF membrane over the implant site.
Single-layer PRF membrane applicationBiological
PRF membrane prepared via centrifugation is applied as a single layer over the implant site following implant placement before flap closure.
Triple-layer PRF membrane applicationBiological
Three autologous PRF membranes prepared via centrifugation are stacked and applied as a 3-layer membrane over the implant site before flap closure.
| Study group | Role | What they receive |
|---|---|---|
| 0 PRF | Active comparator | Each implant placed in this group did NOT have PRF membrane placed over the implant. Receives: Procedure: Dental implant placement without PRF |
| 1 PRF | Experimental | Each implant placed in this group had ONE PRF membrane placed over the implant. Receives: Biological: Single-layer PRF membrane application |
| 3 PRF | Experimental | Each implant placed in this group had THTEE STACKED PRF membranes placed over the implant. Receives: Biological: Triple-layer PRF membrane application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ridge Width Changes (RW)
The changes in Ridge Width is measured at the reference points using a digital vernier caliper.
Measured: Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks
Bone Width (BW)
Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width.
Measured: Baseline (preoperative), and 12 weeks postoperatively
Change in width of keratinized tissue (KTW)
Measured in millimeters at the mid-buccal aspect of the implant site using an endodontic rotary file and digital vernier caliper.
Measured: Baseline (preoperative), 6 weeks, and 12 weeks
Keratinized Tissue Thickness (KTT)
Measured in millimeters at the buccal, crestal and lingual reference points using a periodontal probe and a digital vernier caliper.
Measured: Baseline (preoperative), and 12 weeks postoperatively
Radiographic Mucosal Thickness (RT)
Measured in millimeters on periapical radiographs using digital software from the crestal bone level to the crest of crestal oral mucosa 5 mm away from the height distal surface of the adjacent tooth on the mesial side of the implant.
Measured: Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks
Crestal Bone Height (BH)
Measured in millimeters on periapical radiographs using digital software from the second serration on the mesial side of the implant to the crest of the bone.
Measured: Immediate postoperative, 6 weeks, and 12 weeks
Secondary outcomes (2)
Plaque Index (PI)
O'Leary plaque index
Measured: Baseline (preoperative), 6 weeks, and 12 weeks
Gingival Index (GI)
Gingival Bleeding Index
Measured: Baseline (preoperative), 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Feb 2025
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahir Tawfeeq Karakchi, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033351
- Sponsor's protocol ID
- MUOSU-202131
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet Rich Fibrin Layers on Peri-implant Tissue Phenotype
- ClinicalTrials.gov ID
- NCT07033351
- Acronym / sponsor ID
- MUOSU-202131
- Keywords
- Platelet-Rich Fibrin (PRF), Dental Implant, Keratinized Mucosa, Crestal Bone Level, Soft Tissue Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 24 Jun 2025 (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 present investigation seeks to determine how varying quantities of Platelet-Rich Fibrin (PRF) membranes influence the repair of both gingival and osseous tissues adjacent to dental implants. A secondary objective is to establish whether the incorporation of PRF contributes to enhanced stability of the soft-tissue cover and more effective retention of alveolar bone over an extended period.
Central to the study are two specific inquiries: Does the application of PRF correlate with an increase in the width and thickness of keratinized mucosa surrounding the implant? Is there a dose-response relationship such that the use of multiple PRF layers yields superior maintenance of bone height compared with a single layer or no PRF at all?
To address these questions, clinicians will juxtapose three treatment groups: one receiving no PRF, another receiving a single membrane, and a third receiving a triple-layer graft. Healing parameters will be measured before surgery and again at 6-week and 12-week checkpoints, allowing direct appraisal of outcome changes across the comparative cohorts.
Each participant will ultimately be allotted to one of the experimental arms by random assignment, thus mitigating selection bias. Routine follow-up examinations and radiographic imaging, will be used to track healing progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0 PRF | Active comparator | Procedure: Dental implant placement without PRFEach implant placed in this group did NOT have PRF membrane placed over the implant. |
| 1 PRF | Experimental | Biological: Single-layer PRF membrane applicationEach implant placed in this group had ONE PRF membrane placed over the implant. |
| 3 PRF | Experimental | Biological: Triple-layer PRF membrane applicationEach implant placed in this group had THTEE STACKED PRF membranes placed over the implant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (male or female) over 18 years of age.
- Partially edentulous spaces.
- No history of bone augmentation procedures in the implant site.
- Good oral health, as measured by:
- Calibrated gingival bleeding index (≤10%)
Key exclusion criteria (6 listed)
- Bleeding disorders.
- Compromised immune systems.
- Excessive smoking or alcohol consumption.
- Poor oral hygiene.
- Diabetes.
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 |
|---|---|---|
| Dental implant placement without PRFStandard dental implant placement procedure with flap elevation and suturing, without the application of any PRF membrane over the implant site. | Procedure or surgery | 0 PRF |
| Single-layer PRF membrane applicationPRF membrane prepared via centrifugation is applied as a single layer over the implant site following implant placement before flap closure. | Biological | 1 PRF |
| Triple-layer PRF membrane applicationThree autologous PRF membranes prepared via centrifugation are stacked and applied as a 3-layer membrane over the implant site before flap closure. | Biological | 3 PRF |
Primary outcome
Ridge Width Changes (RW)
Time frame: Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks
The changes in Ridge Width is measured at the reference points using a digital vernier caliper.
Bone Width (BW)
Time frame: Baseline (preoperative), and 12 weeks postoperatively
Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width.
Change in width of keratinized tissue (KTW)
Time frame: Baseline (preoperative), 6 weeks, and 12 weeks
Measured in millimeters at the mid-buccal aspect of the implant site using an endodontic rotary file and digital vernier caliper.
Keratinized Tissue Thickness (KTT)
Time frame: Baseline (preoperative), and 12 weeks postoperatively
Measured in millimeters at the buccal, crestal and lingual reference points using a periodontal probe and a digital vernier caliper.
Radiographic Mucosal Thickness (RT)
Time frame: Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks
Measured in millimeters on periapical radiographs using digital software from the crestal bone level to the crest of crestal oral mucosa 5 mm away from the height distal surface of the adjacent tooth on the mesial side of the implant.
Crestal Bone Height (BH)
Time frame: Immediate postoperative, 6 weeks, and 12 weeks
Measured in millimeters on periapical radiographs using digital software from the second serration on the mesial side of the implant to the crest of the bone.
2 secondary outcomes
Plaque Index (PI)
Time frame: Baseline (preoperative), 6 weeks, and 12 weeks
Gingival Index (GI)
Time frame: Baseline (preoperative), 6 weeks, and 12 weeks
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 27 Jun 2025.
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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 Dental implant placement without PRF, Single-layer PRF membrane application and Triple-layer PRF membrane application in people with Dental Implant and Platelet Rich Fibrin, run by Al-Mustansiriyah University at 1 site in Iraq.
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 6 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: finished, as of the sponsor's last update on 27 Jun 2025. 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 Iraq. 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?
Ridge Width Changes (RW) (time frame: Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks). 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 27 Jun 2025.