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To develop a gum massaging device for persons who dont have any teeth and to determine the usage of the device.

Developing an innovative gingival massaging device for completely edentulous patients and formulating its treatment regimen.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028517
Enrollment
120
Registered
2020-10-21
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: Z768- Persons encountering health services in other specified circumstances

Interventions

Intervention1: nil: nil Intervention2: gingival massaging device: A device will be fabricated and its efficacy will be evaluated. Control Intervention1: Manual gingival massaging using fingers: An ele

Sponsors

Krishna Institute of Medical Sciences Deemed to be University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All edentulous patients who require complete denture prosthesis and willing to participate in the study.

Exclusion criteria

Exclusion criteria: Partially and complete dentulous patient (having one or more teeth present in mouth). SAll patients not willing to participate in the study.

Design outcomes

Primary

MeasureTime frame
The device with its massaging action on gingival, is expected to increase gingival blood flow thereby reduce the rate of resorption of the alveolar bone (which is a continuous and irreversible process after tooth extraction). The reduced rate will keep the dental prosthesis foundation healthy and stable thereby improving nutrition and general well being of the completely edentulous geriatric patient.Timepoint: At baseline and after 1 year of usage of device

Secondary

MeasureTime frame
The massaging action is expected to prevent deterioration of gingival health.Timepoint: At baseline and after one year of usage of device

Countries

India

Contacts

Public ContactSHIVSAGAR TEWARY

Krishna Institute of Medical Sciences Deemed to be University

anandjoshikarad@yahoo.com

Outcome results

None listed

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