NCT05129267

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2022

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

November 10, 2021

Last Update Submit

November 10, 2021

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (6)

  • Probing Depth (PD)

    6 months

  • Clinical Attachment Level (CAL)

    6 months

  • Gingival Marginal Level (GML)

    6 months

  • Plaque Index (PI)

    6 months

  • Intraoral Radiographs

    6 months

  • +1 more secondary outcomes

Study Arms (3)

Group B

ACTIVE COMPARATOR

Scaling and Root Debridement + iPRF

Other: Group B

Group C

ACTIVE COMPARATOR

Scaling and Root Debridement + iPRF +Vitamin C

Other: Group C

Group A

NO INTERVENTION

Scaling and Root Debridement

Interventions

Group BOTHER

Scaling and Root debridement + iPRF

Group B
Group COTHER

Scaling and Root debridement + iPRF together with vitamin C

Group C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medecine-CU

Cairo, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40410805DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Mohamed Ab Sherif

CONTACT

01118222827mohamedsherif@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 10, 2021

First Posted

November 22, 2021

Study Start

October 3, 2021

Primary Completion

June 2, 2022

Study Completion

June 2, 2022

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations

EG(1)