Evaluation of pain response and gingival trauma of PP/NR 3D printed rubber dam clamp compared with conventional metal clamp : A randomized clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260308002

Enrollment

Registered

2026-03-08

Start date

2026-01-30

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

Mild gingival trauma during rubber dam clamp application Discomfort from dental clamp pressure during isolation procedures Rubber dam clamp Pain Gingival trauma Randomized Controlled Trial Polypropylene Natural rubber

Interventions

Patients will receive the PP/NR rubber dam clamp during their first visit, which involves the root canal obturation procedure. Following a washout period of at least two weeks, to eliminate any carryo

Experimental Device,Active Comparator Device

PP/NR rubber dam clamp,Metal rubber dam clamp

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Male or Female 2.Age over 20 years 3.Free from systemic diseases 4.No chronic or acute pain conditions 5.No local anesthesia, systemic sedatives, or painkiller medications during appointment 6.Healthy gingivae status or mild inflammation 7.Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Psychiatric disorders, osteoporosis, or neurological diseases 2. Latex allergies 3. Those with orofacial pain 4. Fear of dental treatment 5. Currently undergoing treatment with analgesics or drugs that might affect pain perception 6. Taken analgesics within 8 hours before the study 7. History of prolonged numbness after impacted tooth removal 8. Molar that is: * Partially erupted * Exhibiting periodontal attachment loss * Having anatomical variations or misalignment preventing stable four-point contact 9. Gingival tissue that bleeds easily upon probing

Design outcomes

Primary

Measure	Time frame
Pain intensity 3 minutes after clamp placement Visual Analogue Scale (VAS)	—

Secondary

Measure	Time frame
Gingival trauma Immediately after clamp removal Gingival trauma by Shah and Kothari criteria mild equals gingival indentation without bleeding moderate equals bleeding without laceration severe equals gingival laceration after clamp placement	—

Countries

Thailand

Contacts

Public ContactPattranith Karnjanamayoon

Faculty of Dentistry, Thammasat University

parewaptn@gmail.com025644441

Outcome results

None listed

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