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A clinical study to evaluate the effectiveness of GapSeal in reducing bacterial contamination around dental implants in patients with Type 2 Diabetes Mellitus.

Evaluate the effect of gapseal as a sealing material at implant abutment interface in type 2 diabetes patient - Split mouth randomised clinical trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105955
Enrollment
12
Registered
2026-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: K084- Partial loss of teeth

Interventions

Intervention1: GapSeal: GapSeal material will be applied at the implant abutment interface prior to abutment connection on the test side. Single application at the time of abutment connection(one time

Sponsors

Priyadharshini K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Partially edentulous patients with bilaterally missing mandibular posterior teeth, willing for implant-supported prosthesis. 2. Patients with controlled type II diabetes (HbA1c less than or equal to 7).

Exclusion criteria

Exclusion criteria: 1.Patients with systemic conditions other than diabetes that could affect surgical outcomes. 2.Smokers. 3.Patients undergoing bisphosphonate therapy. 4.Patients with psychological disorders. 5.Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Quantitative assessment of Porphyromonas gingivalis colonization using real-time PCR.Timepoint: Baseline, 2 weeks, 4 weeks, and 12 weeks post-abutment connection.—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactN. Shanmuganathan

Sri Ramachandra Dental College and Hospital, SRIHER.

d0322007@sriher.edu.in9940087842

Outcome results

None listed

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