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A Study Comparing a New Polymer Rubber Dam Clamp with Conventional Rubber Dam Clamps in Dental Patients: Evaluation of Gum Injury, Comfort, and Clamp Stability

Clinical Evaluation of a Novel Atraumatic Rubber Dam Clamp Compared with a Conventional Rubber Dam Clamp for Dental Isolation: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112503
Enrollment
60
Registered
2026-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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: Novel PLA Based Polymer Rubber Dam Clamp: Custom designed three dimensional printed polylactic acid polymer rubber dam clamp used for isolation during dental procedures. Control Interve

Sponsors

Dr KHUSHI DUA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 60 years. 2. Patients requiring rubber dam isolation for endodontic or restorative dental procedures on permanent posterior teeth. 3. Teeth with adequate coronal structure for clamp placement. 4. Patients willing to participate and provide written informed consent. 5. Patients available for immediate and follow up evaluation.

Exclusion criteria

Exclusion criteria: 1. Patients with known allergy or hypersensitivity to polymer materials. 2. Patients with severe periodontal disease around the study tooth. 3. Teeth with extensive coronal destruction preventing proper clamp placement. 4. Patients with acute oral soft tissue lesions in the area of treatment. 5. Pregnant or lactating women. 6. Patients unwilling to participate or provide informed consent.

Design outcomes

Primary

MeasureTime frame
Gingival trauma score following rubber dam clamp placement.Timepoint: Baseline before clamp placement, immediately after clamp placement, at completion of the procedure, 24 hours post procedure, and 7 days post procedure.

Secondary

MeasureTime frame
Patient discomfort assessed using Visual Analog Scale.Timepoint: Immediately after clamp placement and after completion of the procedure.;Clamp stability measured by incidence of clamp slippage or displacement.Timepoint: Throughout the dental procedure.;Operator ease of placement and removal of the clamp.Timepoint: Immediately after clamp placement and removal.

Countries

India

Contacts

Public ContactDr Manish Ranjan

Saveetha dental college

152406007.sdc@saveetha.com9974931565

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026