comparative study between digitally fabricated complete denture and conventional complete denture

Not yet recruiting

Conditions: Other Procedures, (2) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,

Registration Number: CTRI/2020/03/024165

Lead Sponsor: B T Pradeep Raja

Brief Summary: Conventionalmethod of fabricating Complete Dentures [CD] has been in practice since 1860â€™s . Bilateral Balanced articulation have been proposed as one of the functionallyadvantageous Denture System in terms of stability, even distribution of forcesand denture comfort . Conventional Complete Dentures and Denturesconstructed with Bilateral balanced Articulation has the additional advantageof predictable aesthetics, as individualised teeth arrangement is possibleincluding characterisation of pink and white aesthetics. Through the years, thecontinuing goal was to overcome all the drawbacks associated with the processof fabrication, and enhancements of the properties of materials used fordenture base and teeth. No significant changes were noted in theimpression making and jaw relation procedures involved with conventionalcomplete denture fabrication. Theintroduction and evolution of computer-aided technology in the field of CDfabrication has considerably reduced the time spent in fabrication and theyclaim with the availability of the necessary armamentarium dentures can befabricated in a single day . The first scientific paper on theuse of a computer-aided system for designing and fabricating CDs was publishedby Maeda et al., in 1994, and these dentures were made by additive RapidPrototyping [RP] technology, from photo-polymerised acrylate material using a3-dimensional Laser Lithographic (LL) machine. It took almost 20years for the emergence of the first commercially available denture systems. Very fewstudies and reports are available on the outcome evaluation of the newlyintroduced Baltic system . The advantage of time and simplicity ofthe procedure have attracted the clinicians and have urged them to cater to thedemanding patients overlooking the cost which is involved in the process.With thementioned advantages and disadvantages of the two systems, it is planned toconduct a clinical trial to study the functional and aesthetic outcomes of thepatient with conventional complete denture system with bilateral balancedarticulation and Baltic denture system.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 8

Inclusion Criteria

1.Completely edentulous patients with class I ridge relation, Class I &II ridge morphology (PDI).
2.Adult patients needing new complete dentures 3.Mentally receptiveness 4.Patients able to understand the informed consent 5.Patient who are able to come for 9-10 visits.
6.Absence of dysfunctional disorders of the masticatory system 7.Absence of debilitating systemic diseases.

Exclusion Criteria

1.Refusal to participate in the study.
2.Patients with class II and class III ridge relation.
3.Patients with past history of Complete dentures 4.Symptoms of Temporomandibular disorders 5.Patients with severe xerostomia 6.Patients with parafunctional habits 7.Patients with severe oral manifestations of systemic disease 8.Psychologic or psychiatric conditions that could influence response to treatment.
9.Patient asking for implant supported/retained prostheses.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Functional outcomes - Blinded evaluation of retention and stability using functional assessment of denture - FAD questionnaire	After one month of each intervention
2.Aesthetic outcomes - blinded evaluation of aesthetics using Frush and Fisher Aesthetics criteria	After one month of each intervention
3.Patient satisfaction	After one month of each intervention
4.Comfort- self evaluation of patients satisfaction and comfort by means of a denture satisfaction questionnaire	After one month of each intervention

Secondary Outcome Measures

Name	Time	Method
PATIENT QUALITY OF LIFE assessment of patients quality of life (OHRQoL) before and after treatment by means of Oral Health Impact Profile Questionnaire (OHIP19)	AFTER ONE MONTH OF EACH INTERVENTION

Trial Locations

Locations (1): Indira Gandhi Institute of Dental Sciences
🇮🇳
Pondicherry, PONDICHERRY, India
Indira Gandhi Institute of Dental Sciences
🇮🇳Pondicherry, PONDICHERRY, India
B T Pradeep Raja
Principal investigator
9976349663
pradeeprajabt@gmail.com