A pilot study to evaluate the safety and performance of PoroSyn, a synthetic bone graft, in a socket preservation procedure

Evaluation of the safety and efficacy of PoroSyn, a synthetic bone graft in alveolar ridge augmentation - A single centre, open-label, randomized, comparative pilot study - PoroSyn Pilot Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/032737

Enrollment

Registered

2021-04-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: X- New Technology

Interventions

Intervention1: PoroSyn Bioactive Synthetic Bone Graft Granules: PoroSyn (Synthetic Bone Graft Granules) is a largely porous bioactive glass material used for alloplastic bone grafting. PoroSyn is comp

Eligibility

Inclusion criteria

Inclusion criteria: 1. Need for tooth extraction 2. Subject aged between 18-45 years of age belonging to either sex 3. Non - smokers 4. Presence of healthy adjacent teeth to the tooth to be extracted 5. Medically fit and healthy patient, able to undergo oral surgical procedure under local anesthesia 6. Subjects with good oral hygiene 7.Able to sign Informed Consent

Exclusion criteria

Exclusion criteria: -Patients requiring extraction of third molars -Acute infection or pus at the extraction site -Habits (Smoking, tobacco/ Beetle nut chewing) -Pregnant and lactating subjects -Presence of active periodontal disease -Subjects with poor oral hygiene and motivation -Subjects addicted to drugs or alcohol -Patients with psychiatric problem -Patients with condition affecting bone -Patients who are taking immunosuppressant medication -Patients who are taking anti-coagulant medication -Patients who have had or are undergoing radiation treatment of the graft region. -Patients with uncontrolled systemic diseases

Design outcomes

Primary

Measure	Time frame
To determine safety and stability of Porosyn in oral and dental intraosseous defectsTimepoint: Screening, procedure, day 1, week 1, month 1, month 3, month 6	—

Secondary

Measure	Time frame
1. To determine the amount of bone growth at the extraction site. 2. To evaluate the soft tissue healing at the extraction site. 3. To evaluate the potential of Porosyn in conditions like Cystectomy or Apicoectomy Procedures, Sinusotomy-Maxillary Sinus Elevation, Osteotomy Procedures, Ridge Augmentation requiring bone grafting, Implant procedures. Timepoint: Same as above	—

Countries

India

Contacts

Public ContactDr Nilay Lakhkar

SynThera Biomedical Pvt Ltd

nilay@synthera.in9892859665

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026