PeriodontitisNCT05129267
Evaluation of iPRF With Vitamin C in StageII Grade A Periodontitis
A study testing Group B and Group C in people with Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
Comparing the effect of using vitamin C with injectable PRF as a locally delivered adjunct to scaling and root planing versus scaling and root planing with local delivery of injectable PRF and scaling and root planing alone on the clinical parameters in Stage II Grade A Periodontitis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Group B and Group C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Oct 2021to 2 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- Patients with Stage II Grade A periodontitis.
- Patients accept 6-months follow-up period (cooperative patients).
- Patients provide an informed consent.
Who cannot join
- Presence of prosthetic crowns.
- Extensive restorations.
- Periodontal therapy within the last 12 months.
- Having surgical therapy or undergoing orthodontic treatment.
- Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
- The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.
- Smokers.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medecine-CU
Cairo
Mohamed Ab Sherif, Master, 01118222827, mohamedsherif@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Injectable PRF With Vitamin C as an Adjunct to Non-surgical Therapy in the Treatment of Stage II Grade A Periodontitis. A Randomized Controlled Clinical Trial
Comparing the effect of using vitamin C with injectable PRF as a locally delivered adjunct to scaling and root planing versus scaling and root planing with local delivery of injectable PRF and scaling and root planing alone on the clinical parameters in Stage II Grade A Periodontitis patients.
Read the detailed description
The conventional approach:
Group 1: Scaling and root planing alone using Gracey curettes and ultrasonic scalers.
Group 2: Scaling and root planing using Gracey curettes and ultrasonic scalers with local delivery of injectable PRF using an insulin syringe with the blunt needle inserted into the bottom of the periodontal pocket through a template to hold the locally delivered injectable PRF.
The intervention approach:
Scaling and root planing using Gracey curettes and ultrasonic scalers with local delivery of vitamin C (250 μM) and injectable PRF, using an insulin syringe with the blunt needle inserted into the bottom of the periodontal pocket through a template to hold the locally delivered vitamin C and injectable PRF for a longer time.
- Conditions
- Periodontitis
- Being tested
- Group B, Group C
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group BOther
Scaling and Root debridement + iPRF
Group COther
Scaling and Root debridement + iPRF together with vitamin C
| Study group | Role | What they receive |
|---|---|---|
| Group B | Active comparator | Scaling and Root Debridement + iPRF Receives: Other: Group B |
| Group C | Active comparator | Scaling and Root Debridement + iPRF +Vitamin C Receives: Other: Group C |
| Group A | No intervention | Scaling and Root Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing (BOP)
Gentle probing of the orifice of the gingival crevice. The periodontal probe will be inserted 1 to 2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.
Measured: 3 months
Secondary outcomes (6)
Probing Depth (PD)
Measured from the gingival margin to the bottom of the gingival sulcus. Each tooth will be probed with a light force not exceeding 25 grams at 6 sites.
Measured: 6 months
Clinical Attachment Level (CAL)
Measured from the CEJ to the bottom of the gingival sulcus, or will be calculated as the algebraic sum of gingival recession and PD measurements for each site. Each tooth will be probed with a light force not exceeding 25 grams at six points: (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual).
Measured: 6 months
Gingival Marginal Level (GML)
Measured from the free gingiva to CEJ.
Measured: 6 months
Plaque Index (PI)
Teeth in each quadrant will be dried with a blast of air, and presence of visible dental plaque will be recorded with scores 0, 1, 2, 3.
Measured: 6 months
Intraoral Radiographs
A customized X-ray positioning stent will be fabricated to allow easy and accurate radiographing and retain the plastic film holder in the paralleling radiographic technique.
Measured: 6 months
Post-Operative Pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperatively.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start3 Oct 2021
- Primary completion2 Jun 2022 (estimated)
- Study completion2 Jun 2022 (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 PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdulhakim Mohamed Sherif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129267
- Sponsor's protocol ID
- PER 3- 3- 2
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sherif MA, Anter E, Graetz C, El-Sayed KF. Injectable platelet-rich fibrin with vitamin C as an adjunct to non-surgical periodontal therapy in the treatment of stage-II periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2025 May 23;25(1):772. doi: 10.1186/s12903-025-06115-x.
PubMed 40410805
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Injectable PRF With Vitamin C as an Adjunct to Non-surgical Therapy in the Treatment of Stage II Grade A Periodontitis. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05129267
- Acronym / sponsor ID
- PER 3- 3- 2
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 2 Jun 2022 (estimated)
- Study completion
- 2 Jun 2022 (estimated)
- First posted
- 22 Nov 2021 (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.
Comparing the effect of using vitamin C with injectable PRF as a locally delivered adjunct to scaling and root planing versus scaling and root planing with local delivery of injectable PRF and scaling and root planing alone on the clinical parameters in Stage II Grade A Periodontitis patients.
Detailed description
The conventional approach:
Group 1: Scaling and root planing alone using Gracey curettes and ultrasonic scalers.
Group 2: Scaling and root planing using Gracey curettes and ultrasonic scalers with local delivery of injectable PRF using an insulin syringe with the blunt needle inserted into the bottom of the periodontal pocket through a template to hold the locally delivered injectable PRF.
The intervention approach:
Scaling and root planing using Gracey curettes and ultrasonic scalers with local delivery of vitamin C (250 μM) and injectable PRF, using an insulin syringe with the blunt needle inserted into the bottom of the periodontal pocket through a template to hold the locally delivered vitamin C and injectable PRF for a longer time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group B | Active comparator | Other: Group BScaling and Root Debridement + iPRF |
| Group C | Active comparator | Other: Group CScaling and Root Debridement + iPRF +Vitamin C |
| Group A | No intervention | –Scaling and Root Debridement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- Patients with Stage II Grade A periodontitis.
- Patients accept 6-months follow-up period (cooperative patients).
- Patients provide an informed consent.
Key exclusion criteria (8 listed)
- Presence of prosthetic crowns.
- Extensive restorations.
- Periodontal therapy within the last 12 months.
- Having surgical therapy or undergoing orthodontic treatment.
- Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
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 |
|---|---|---|
| Group BScaling and Root debridement + iPRF | Other | Group B |
| Group CScaling and Root debridement + iPRF together with vitamin C | Other | Group C |
Primary outcome
Bleeding on Probing (BOP)
Time frame: 3 months
Gentle probing of the orifice of the gingival crevice. The periodontal probe will be inserted 1 to 2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.
6 secondary outcomes
Probing Depth (PD)
Time frame: 6 months
Clinical Attachment Level (CAL)
Time frame: 6 months
Gingival Marginal Level (GML)
Time frame: 6 months
Plaque Index (PI)
Time frame: 6 months
Intraoral Radiographs
Time frame: 6 months
Post-Operative Pain
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Derived from this study: PubMed 40410805Sherif MA, Anter E, Graetz C, El-Sayed KF. Injectable platelet-rich fibrin with vitamin C as an adjunct to non-surgical periodontal therapy in the treatment of stage-II periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2025 May 23;25(1):772. doi: 10.1186/s12903-025-06115-x.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group B and Group C in people with Periodontitis, run by Cairo University 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 5 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: status not confirmed, as of the sponsor's last update on 22 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ab Sherif (01118222827, mohamedsherif@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on Probing (BOP) (time frame: 3 months). 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 NCT05129267, 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 22 Nov 2021.