Oral Submucous FibrosisRegenOSFNCT07277998
Alternating Triamcinolone and Platelet-Rich Plasma Therapy for Oral Submucous Fibrosis
A study testing Platelet-Rich Plasma (PRP) Injections and Triamcinolone Acetonide in people with Oral Submucous Fibrosis, run by Karachi Medical and Dental College at 1 site in Pakistan.
Trial summary
Oral Submucous Fibrosis (OSF) is a chronic, progressive, potentially malignant disorder characterized by mucosal stiffness, trismus, and burning sensation. This interventional clinical trial evaluates the therapeutic effectiveness of alternating weekly intralesional Triamcinolone Acetonide (TA) and Platelet-Rich… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oral Submucous Fibrosis
- What is being tested?
- Platelet-Rich Plasma (PRP) Injections and Triamcinolone Acetonide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed Oral Submucous Fibrosis (OSF), Stage II-IV using Haider et al. classification.
- Age 18-65 years. Mouth opening ≤ 30 mm. Persistent burning sensation (VAS ≥ 3). Able and willing to comply with weekly therapy sessions. Provided written informed consent.
Who cannot join
- Previous treatment with PRP, Platelet-rich Fibrin (PRF), corticosteroid, or combination therapy in the last 6 months.
- Systemic diseases affecting wound healing (e.g., uncontrolled diabetes, severe anemia).
- Current steroid therapy or immunosuppressive therapy.
- Oral lesions suspicious for malignancy or recurrent Oral Squamous cell carcinoma (OSCC).
- Bleeding disorders or platelet count <150,000.
- Pregnant or breastfeeding women.
- Known allergy to local anesthetics or triamcinolone.
- Patients unwilling to stop areca nut/tobacco habits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Abbasi Shaheed Hospital
Karachi, Sindh, 71510
Madiha Khan, BDS, MS, +923350250691, dr.khanmadiha@gmail.com
Aisha Faraz, BDS, MS, +923333096619, Aishazafar212@gmail.com
About this study
Official title: Clinical Efficacy of Alternating Intralesional Triamcinolone Acetonide and Platelet-Rich Plasma Compared to Triamcinolone Alone in Patients With Oral Submucous Fibrosis: A Two-Arm Interventional Clinical Trial
Oral Submucous Fibrosis (OSF) is a chronic, progressive, potentially malignant disorder characterized by mucosal stiffness, trismus, and burning sensation. This interventional clinical trial evaluates the therapeutic effectiveness of alternating weekly intralesional Triamcinolone Acetonide (TA) and Platelet-Rich Plasma (PRP) injections compared to standard Triamcinolone therapy alone. The purpose is to determine whether sequential anti-inflammatory (TA) and regenerative (PRP) stimulation can produce superior clinical improvement in mouth opening, burning sensation, and mucosal flexibility compared to corticosteroid therapy alone.
Read the detailed description
Oral Submucous Fibrosis (OSF) is a chronic, irreversible fibro-elastic disorder of the oral mucosa associated with restricted mouth opening, burning sensation, impaired mastication, and decreased quality of life. Traditional management approaches include intralesional corticosteroids, physiotherapy, antioxidants, and more recently, regenerative therapies such as Platelet-Rich Plasma (PRP).
Triamcinolone Acetonide (TA) provides anti-inflammatory and anti-fibrotic effects by suppressing fibroblast activity and collagen deposition. PRP, an autologous concentrate of platelets and growth factors, has demonstrated potential in promoting angiogenesis, collagen remodeling, and mucosal regeneration. Alternating TA and PRP may theoretically combine the immediate anti-inflammatory benefits of TA with the long-term regenerative benefits of PRP, resulting in more effective improvement of OSF symptoms.
This study consists of two arms. In the control arm, participants will receive weekly intralesional Triamcinolone injections for 6 weeks. In the experimental arm, participants will receive Triamcinolone in Week 1, PRP in Week 2, followed by alternating TA and PRP injections for a total of 6 weeks. All participants will be instructed to perform standardized jaw physiotherapy exercises during the study period.
Primary outcomes include change in interincisal mouth opening (millimeters) and reduction in burning sensation using a Visual Analog Scale (VAS). Secondary outcomes include mucosal flexibility score, cheek rigidity grading, functional improvement during mastication and speech, and patient satisfaction.
This clinical trial aims to generate high-quality comparative evidence regarding whether an alternating TA-PRP protocol offers superior therapeutic outcomes compared to conventional corticosteroid therapy alone, thereby supporting advancement of regenerative treatment protocols for OSF within oral and maxillofacial clinical practice.
- Conditions
- Oral Submucous Fibrosis
- Being tested
- Platelet-Rich Plasma (PRP) Injections, Triamcinolone Acetonide
- Keywords
- Triamcinolone acetonide, Platelet-rich plasma, Regenerative therapy, Oral mucosal disorders, Fibrosis, OSF, Intralesional therapy, Oral and maxillofacial surgery, Steroid injection, Mouth opening, Burning sensation, Oral precancerous lesions, Stem cell mediated healing, Collagen remodeling, Areca nut, Trismus, Limited mouth opening, LMO, BMS, OMFS
- Medical subject headings
- Oral Submucous Fibrosis, Fibrosis, Paresthesia, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma (PRP) InjectionsBiological
Also called PRP
Autologous Platelet-rich plasma (PRP) injected intralesionally at standard volume for Oral submucous fibrosis (OSF) treatment, administered every alternate week.
Triamcinolone AcetonideDrug
Also called TA
Triamcinolone acetonide 10 mg/mL administered intralesionally once weekly.
| Study group | Role | What they receive |
|---|---|---|
| Alternating Triamcinolone + PRP Therapy | Active comparator | Patients will receive alternating-week intralesional Triamcinolone (10 mg/mL) and Platelet-Rich Plasma therapy. Triamcinolone is given in Week 1, PRP in Week 2, and alternated weekly for a total of 6-8 sessions. Receives: Biological: Platelet-Rich Plasma (PRP) Injections; Drug: Triamcinolone Acetonide |
| Triamcinolone Alone Therapy | Active comparator | Patients will receive intralesional Triamcinolone acetonide (10 mg/mL) once weekly for 6-8 sessions as standard therapy. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mouth Opening (Interincisal Distance in mm)
Mouth opening will be measured using a digital caliper from incisal edge to incisal edge at baseline and at each follow-up visit. The primary endpoint is the change in interincisal distance from baseline to 8 weeks and 12 weeks.
Measured: Baseline, Week 4, Week 8, Week 12
Change in Burning Sensation (VAS Score 0-10)
Burning sensation will be assessed using the Visual Analog Scale (VAS), where 0 indicates no burning and 10 indicates the worst possible burning.
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (3)
Change in Clinical Grade of OSMF
Oral Submucous Fibrosis (OSF) severity will be assessed using a standardized clinical grading system that evaluates mouth opening, fibrous banding, mucosal texture, and burning sensation. Grades range from Grade I (mild) to Grade IV (severe). Higher grades indicate more advanced disease. Improvement or worsening will be determined by comparing baseline and Week 12 assessment
Measured: Baseline and Week 12
Change in Cheek Flexibility (mm)
Cheek flexibility will be measured using Mathur and Jha method at baseline and follow-up visits.
Measured: Baseline, Week 8, Week 12
Incidence of Treatment-Related Adverse Events
All adverse events such as swelling, pain, ulceration, infection, or allergy will be recorded throughout the study period.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study startMar 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Oral Submucous FibrosisStudies 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
- Model description
- Two-arm parallel assignment comparing alternating-week Triamcinolone + PRP therapy vs standard single-agent therapy
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karachi Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madiha Khan, Karachi Medical and Dental College
- Investigators
- Sufyan Ahmed, BDS, FCPS, Study chair, Karachi Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277998
- Sponsor's protocol ID
- MK_OSF_ALTTA_PRP_2025
- Other IDs
- KMDC/OMFS/OSF-CombTherapy/2025
- Acronym
- RegenOSF
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset will be used for future analyses, internal audits, and subsequent publications by the study team. Data will remain confidential and securely stored according to institutional policy.
Publications
Khan M, Ahmed S, Faraz A, Ali Z, Khan S, Iqbal M. Comparison Between Treatment of Oral Submucous Fibrosis with Intralesional Triamcinolone Injection Versus Platelet-Rich Plasma. Journal of Population Therapeutics and Clinical Pharmacology. 2025;32(4):166-172.
Alsousou J, Thompson M, Hulley P, Noble A, Willett K. The biology of Platelet-Rich Plasma and regenerative potential in tissue healing. Am J Sports Med. 2009;37(11):2259-2272. PMID: 19088268.
Tilakaratne WM, Klinikowski MF. Intralesional corticosteroid injection as a treatment modality for oral submucous fibrosis. J Oral Pathol Med. 2016;45(3):162-168. PMID: 27422421.
Saraf K, Gaur A, Thomas R. Efficacy of Platelet-Rich Plasma injections in Oral Submucous Fibrosis: A Prospective Clinical Study. Dent Res Dent Clin Dent Prospects. 2021;15(4):275-280. PMID: 34912641.
OSF Singh S, Misra N. Comparative evaluation of intralesional platelet-rich plasma and intralesional corticosteroid in management of oral submucous fibrosis. J Oral Maxillofac Pathol. 2020;24(1):121-126. PMID: 33584414.
Ali H, Ahmed S, Raza SH. Effect of intralesional injection of triamcinolone acetonide in oral submucous fibrosis. Journal of Surgery Pakistan. 2019;24(4):181-185.
Haider SM, Merchant A, Fida M. Clinical grading of oral submucous fibrosis: A practical classification for patient severity assessment. Journal of Pakistan Dental Association. 2016;25(4):147-152.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Alternating Intralesional Triamcinolone Acetonide and Platelet-Rich Plasma Compared to Triamcinolone Alone in Patients With Oral Submucous Fibrosis: A Two-Arm Interventional Clinical Trial
- ClinicalTrials.gov ID
- NCT07277998
- Acronym / sponsor ID
- RegenOSF / MK_OSF_ALTTA_PRP_2025
- Conditions
- Oral Submucous Fibrosis
- Keywords
- Triamcinolone acetonide, Platelet-rich plasma, Regenerative therapy, Oral mucosal disorders, Fibrosis, OSF, Intralesional therapy, Oral and maxillofacial surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karachi Medical and Dental CollegeUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Dec 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.
Oral Submucous Fibrosis (OSF) is a chronic, progressive, potentially malignant disorder characterized by mucosal stiffness, trismus, and burning sensation. This interventional clinical trial evaluates the therapeutic effectiveness of alternating weekly intralesional Triamcinolone Acetonide (TA) and Platelet-Rich Plasma (PRP) injections compared to standard Triamcinolone therapy alone. The purpose is to determine whether sequential anti-inflammatory (TA) and regenerative (PRP) stimulation can produce superior clinical improvement in mouth opening, burning sensation, and mucosal flexibility compared to corticosteroid therapy alone.
Detailed description
Oral Submucous Fibrosis (OSF) is a chronic, irreversible fibro-elastic disorder of the oral mucosa associated with restricted mouth opening, burning sensation, impaired mastication, and decreased quality of life. Traditional management approaches include intralesional corticosteroids, physiotherapy, antioxidants, and more recently, regenerative therapies such as Platelet-Rich Plasma (PRP).
Triamcinolone Acetonide (TA) provides anti-inflammatory and anti-fibrotic effects by suppressing fibroblast activity and collagen deposition. PRP, an autologous concentrate of platelets and growth factors, has demonstrated potential in promoting angiogenesis, collagen remodeling, and mucosal regeneration. Alternating TA and PRP may theoretically combine the immediate anti-inflammatory benefits of TA with the long-term regenerative benefits of PRP, resulting in more effective improvement of OSF symptoms.
This study consists of two arms. In the control arm, participants will receive weekly intralesional Triamcinolone injections for 6 weeks. In the experimental arm, participants will receive Triamcinolone in Week 1, PRP in Week 2, followed by alternating TA and PRP injections for a total of 6 weeks. All participants will be instructed to perform standardized jaw physiotherapy exercises during the study period.
Primary outcomes include change in interincisal mouth opening (millimeters) and reduction in burning sensation using a Visual Analog Scale (VAS). Secondary outcomes include mucosal flexibility score, cheek rigidity grading, functional improvement during mastication and speech, and patient satisfaction.
This clinical trial aims to generate high-quality comparative evidence regarding whether an alternating TA-PRP protocol offers superior therapeutic outcomes compared to conventional corticosteroid therapy alone, thereby supporting advancement of regenerative treatment protocols for OSF within oral and maxillofacial clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel assignment comparing alternating-week Triamcinolone + PRP therapy vs standard single-agent therapy
| Arm | Type | Receives |
|---|---|---|
| Alternating Triamcinolone + PRP Therapy | Active comparator | Biological: Platelet-Rich Plasma (PRP) Injections, Drug: Triamcinolone AcetonidePatients will receive alternating-week intralesional Triamcinolone (10 mg/mL) and Platelet-Rich Plasma therapy. Triamcinolone is given in Week 1, PRP in Week 2, and alternated weekly for a total of 6-8 sessions. |
| Triamcinolone Alone Therapy | Active comparator | Drug: Triamcinolone AcetonidePatients will receive intralesional Triamcinolone acetonide (10 mg/mL) once weekly for 6-8 sessions as standard therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically diagnosed Oral Submucous Fibrosis (OSF), Stage II-IV using Haider et al. classification.
- Age 18-65 years. Mouth opening ≤ 30 mm. Persistent burning sensation (VAS ≥ 3). Able and willing to comply with weekly therapy sessions. Provided written informed consent.
Key exclusion criteria (8 listed)
- Previous treatment with PRP, Platelet-rich Fibrin (PRF), corticosteroid, or combination therapy in the last 6 months.
- Systemic diseases affecting wound healing (e.g., uncontrolled diabetes, severe anemia).
- Current steroid therapy or immunosuppressive therapy.
- Oral lesions suspicious for malignancy or recurrent Oral Squamous cell carcinoma (OSCC).
- Bleeding disorders or platelet count <150,000.
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) InjectionsAlso: PRPAutologous Platelet-rich plasma (PRP) injected intralesionally at standard volume for Oral submucous fibrosis (OSF) treatment, administered every alternate week. | Biological | Alternating Triamcinolone + PRP Therapy |
| Triamcinolone AcetonideAlso: TATriamcinolone acetonide 10 mg/mL administered intralesionally once weekly. | Drug | Alternating Triamcinolone + PRP Therapy, Triamcinolone Alone Therapy |
Primary outcome
Change in Mouth Opening (Interincisal Distance in mm)
Time frame: Baseline, Week 4, Week 8, Week 12
Mouth opening will be measured using a digital caliper from incisal edge to incisal edge at baseline and at each follow-up visit. The primary endpoint is the change in interincisal distance from baseline to 8 weeks and 12 weeks.
Change in Burning Sensation (VAS Score 0-10)
Time frame: Baseline, Week 4, Week 8, Week 12
Burning sensation will be assessed using the Visual Analog Scale (VAS), where 0 indicates no burning and 10 indicates the worst possible burning.
3 secondary outcomes
Change in Clinical Grade of OSMF
Time frame: Baseline and Week 12
Change in Cheek Flexibility (mm)
Time frame: Baseline, Week 8, Week 12
Incidence of Treatment-Related Adverse Events
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Results publicationKhan M, Ahmed S, Faraz A, Ali Z, Khan S, Iqbal M. Comparison Between Treatment of Oral Submucous Fibrosis with Intralesional Triamcinolone Injection Versus Platelet-Rich Plasma. Journal of Population Therapeutics and Clinical Pharmacology. 2025;32(4):166-172.
- Results publicationAlsousou J, Thompson M, Hulley P, Noble A, Willett K. The biology of Platelet-Rich Plasma and regenerative potential in tissue healing. Am J Sports Med. 2009;37(11):2259-2272. PMID: 19088268.
- Results publicationTilakaratne WM, Klinikowski MF. Intralesional corticosteroid injection as a treatment modality for oral submucous fibrosis. J Oral Pathol Med. 2016;45(3):162-168. PMID: 27422421.
- Results publicationSaraf K, Gaur A, Thomas R. Efficacy of Platelet-Rich Plasma injections in Oral Submucous Fibrosis: A Prospective Clinical Study. Dent Res Dent Clin Dent Prospects. 2021;15(4):275-280. PMID: 34912641.
- Results publicationOSF Singh S, Misra N. Comparative evaluation of intralesional platelet-rich plasma and intralesional corticosteroid in management of oral submucous fibrosis. J Oral Maxillofac Pathol. 2020;24(1):121-126. PMID: 33584414.
- Results publicationAli H, Ahmed S, Raza SH. Effect of intralesional injection of triamcinolone acetonide in oral submucous fibrosis. Journal of Surgery Pakistan. 2019;24(4):181-185.
- Results publicationHaider SM, Merchant A, Fida M. Clinical grading of oral submucous fibrosis: A practical classification for patient severity assessment. Journal of Pakistan Dental Association. 2016;25(4):147-152.
- Published comparative study on PRP and TA therapy for Oral Submucous Fibrosis by the Principal Investigator.Link provided by the sponsor.
- Institutionally developed OSF clinical grading system used in this trial.Link provided by the sponsor.
- Steroid-based management study of Oral Submucous Fibrosis conducted at the same institution.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset will be used for future analyses, internal audits, and subsequent publications by the study team. Data will remain confidential and securely stored according to institutional policy.
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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.
Sufyan Ahmed, BDS, FCPS study chair
Karachi Medical and Dental 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 Platelet-Rich Plasma (PRP) Injections and Triamcinolone Acetonide in people with Oral Submucous Fibrosis, run by Karachi Medical and Dental College 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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 11 Dec 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madiha Khan, BDS, MS (+923350-250691, Dr.khanmadiha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mouth Opening (Interincisal Distance in mm) (time frame: Baseline, Week 4, Week 8, Week 12). The study lists 2 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 NCT07277998, which also lists 7 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 11 Dec 2025.