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Bioflex Crowns on the Peridontal Health of Primary Molars

Effect of Bioflex Crowns on the Peridontal Health of Primary Molars Indicated by Interleukin One Beta Content of Gingival Crevicular Fluid: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202511815030369
Enrollment
20
Registered
2025-11-17
Start date
2025-01-05
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health

Interventions

Sponsors

Nadine Metwally
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children with two primary molars indicated for pulpotomy and crown placement. Sound tooth to be used as a reference point. 2. Completion of an informed consent to participate in the study. 3. Subjects whose parents consent to receive both stainless-steel crowns and Bioflex crowns.

Exclusion criteria

Exclusion criteria: Children with systemic diseases or special health care needs. Patients showing a lack of compliance (Grade 1 and 2 patients according to Frankl behavior rating scale). Children with generalized gingivitis. 1. The use of antibiotics within a period of 4 weeks before the study until the end of the study. Patients with bruxism. 2. Presence of signs of irreversible pulpitis, periapical infection, abscesses, or mobility. 3. Radiographic signs of furcal or periapical root resorption. 4. Patients with proximal decay.

Design outcomes

Primary

MeasureTime frame
Change in IL-1ß Gingival crevicular fluid will be collected by paper points which will be gently placed for 30 seconds into the gingival crevice until a minimum of resistance is felt. it will be analyzed by ELISA

Secondary

MeasureTime frame
Change in gingival inflammation score The gingival tissues around each tooth will be examined from the mesial, distal, buccal, and lingual areas. Each of those four gingival areas will be scored on a scale from 0 (no inflammation) to 3 (severe inflammation);Change in plaque accumulation The plaque accumulation at the gingival area in each tooth will be examined on the mesial, distal, buccal, and lingual surfaces. Each of these four surfaces will be scored on a scale from 0 to 3 (Abundance amount of plaque)

Countries

Egypt

Contacts

Public ContactNadine Metwally

Postgraduate student

Nadinemetwally@hotmail.com0001271190644

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 10, 2026