Effect of anti-cholesterol drug simvastatin to help in rapid bone healing in tooth extraction sockets

Effect of simvastatin in enhancing bone healing in tooth extraction sockets: A Randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/04/024771

Enrollment

Registered

2020-04-21

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: K029- Dental caries, unspecified

Interventions

Intervention1: Simvastatin plus absorbable gelatin sponge (1cmx1cmx1cm cube): Anti-cholesterol drug (20 mg crushed tablet) which helps increase bone mineral density

along with 1 x 1 x 1 cm cube of absorbable gelatin sponge (which acts as a carrier) Control Intervention1: Absorbable Gelatin sponge (1 x 1 x 1 cm cube): Sterile Hemostatic agent

Eligibility

Inclusion criteria

Inclusion criteria: Tooth requiring non surgical tooth extraction Totally erupted tooth (carious tooth and root stump included)

Exclusion criteria

Exclusion criteria: Patients requiring tooth extraction with age of 18 years or less; or more than 50 years Patient with medical co-morbidities like diabetes, hypertension, cardio-vascular disorders, bleeding disorders; disorders affecting bone metabolism Patient with known cancer or undergoing/having history of radio-therapy/chemo-therapy Patient who are allergic to the drug simvastatin Patients on steroid therapy Tooth requiring surgical tooth extraction Un-erupted or partially erupted tooth Tooth with peri-apical infection (peri-apical granuloma/cyst/abscess) Pregnant patient Patients lost to follow up

Design outcomes

Secondary

Measure	Time frame
To compare pain and swelling at follow up: between case and controlTimepoint: 1 week, 1 month, 2 months, 4 months, 6 months, 8 months;To compare the alveolar ridge height obtained between case and controlTimepoint: 1 week, 1 month, 2 months, 4 months, 6 months, 8 months;To compare the bone mineral density with the control Timepoint: 1 week, 1 month, 2 months, 4 months, 6 months, 8 months;To compare the difference in bone mineral density obtained with the use of simvastatin: on maxilla and mandibleTimepoint: 1 week, 1 month, 2 months, 4 months, 6 months, 8 months;To compare the radiographic bone fill between case and controlTimepoint: 1 week, 1 month, 2 months, 4 months, 6 months, 8 months	—

Measure

Time frame

To compare pain and swelling at follow up: between case and controlTimepoint: 1 week, 1 month, 2 months, 4 months, 6 months, 8 months;To compare the alveolar ridge height obtained between case and controlTimepoint: 1 week, 1 month, 2 months, 4 months, 6 months, 8 months;To compare the bone mineral density with the control Timepoint: 1 week, 1 month, 2 months, 4 months, 6 months, 8 months;To compare the difference in bone mineral density obtained with the use of simvastatin: on maxilla and mandibleTimepoint: 1 week, 1 month, 2 months, 4 months, 6 months, 8 months;To compare the radiographic bone fill between case and controlTimepoint: 1 week, 1 month, 2 months, 4 months, 6 months, 8 months

—

Primary

Measure	Time frame
To study the bone mineral density in extraction socket in cases where simvastatin is used; by gray scale histogram at different time intervals of healingTimepoint: 1 week, 1 month, 2month, 4 months, 6 months, 8 months	—

Countries

India

Contacts

Public ContactDr Ashi Chug

All India Institute of Medical Sciences, Rishikesh

ashichug@gmail.com8475000290

Outcome results

None listed

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