A Randomized Controlled Trial to Compare Patient Satisfaction Related to Denture Teeth Selection by Using Novel Esthetic Strips and a Conventional Method.

The primary consideration for patients seeking prosthetic treatment with missing anterior teeth is esthetics. The size and form of the maxillary anterior teeth are of importance to both dental and facial aesthetics (Vasantha Kumar et al, 2011). Several methods are available for the selection of anterior teeth. Historically, it started with anthropometric measurements such as the bizygomatic width, inter-alar distance, etc., and later advanced to typal form theory, Berry’s biometric ratio method, Wright’s photometric method, etc. (Chander, 2021).

In the present day, a variety of shade guides, mold sizes and measurements are provided by the manufacturers to help aid the clinician in selecting the anterior teeth. The patients cannot visualize the final outcome of their dentures using these methods. Digital dentistry helps the patients in viewing the final outcome of their dentures during a digital trial registration. This method is quite expensive and may not be feasible in developing countries (Varghese, 2022). The most common method used is the arbitrary selection of anterior teeth with the help of mold sizes based on the patient’s opinion and clinician’s experience. It is time-consuming to attach the different molds of acrylic teeth on the occlusion rims by trial and error. In a study conducted by LaVere, it was found that the anterior teeth sizes used in dentures were smaller than the natural teeth sizes. (LaVere et al, 1994 and Ceruti et al, 2013).

In a randomized case control clinical trial, a new inexpensive method of anterior teeth selection was evaluated. With the help of adhesive paper teeth (Major Moncalieri) available in all mold sizes and shapes, the patients could visualize the final outcome comparatively better than the arbitrary method. The adhesive plasticized papers of different teeth could be placed together or separately. This allowed customization and is an advantage of this new technique. The disadvantage is the necessity of remounting due to operator error in attaching the adhesive teeth to the rims (Ceruti, 2013). A new technique of using life-size coloured print of teeth molds has been developed. This helps the patients in the visualization of the aesthetics of their final dentures. A major drawback was that the teeth could not be arranged individually and the visibility of the background colour of the denture base beyond the incisal edges of the teeth make it unaesthetic (Varghese, 2022).  There are not many studies evaluating the patients’ satisfaction of the denture esthetics related to the teeth size. In order to overcome the drawbacks of the previous studies, a novel three-dimensional esthetic dental strip was designed to help the patients visualize the final esthetic outcome of their dentures.

Research Question: Is there any change in the patients’ satisfaction of denture esthetics related to teeth size when the maxillary anterior teeth are selected using novel esthetic strips or the conventional methods?

 Null Hypothesis: There is no change in the patients’ satisfaction of denture esthetics related to teeth size when the maxillary anterior teeth are selected using novel esthetic strips or the conventional methods.

**Aim:**To compare the patient satisfaction related to teeth size when the denture teeth are selected using the novel esthetic strips or by a conventional method.

 Objectives:

1.      To design and develop novel esthetic strips from the commonly used acrylic denture teeth moulds

2.      To select the teeth size for edentulous patients with the help of the novel esthetic strips and by a conventional method

3.      To compare the patient satisfaction related to the size of the artificial teeth when the denture teeth are selected using either of the two methods

Sample size determination:

The sample size was estimated using the G power software v.3.1.9.2.

Analysis: A priori: Compute required sample size

Input:           Tail(s)                                             =   Two

Effect size d                                  =   0.7

α err prob                                     =   0.05

Power (1-β err prob)                 =   0.85

Allocation ratio N2/N1             =   1

Output:       Noncentrality parameter δ     =   2.7559028

Critical t                                         =   1.6706489

Df                                                    =   60

Sample size group 1                  =   31

Sample size group 2                  =   31

Total sample size                       =   62

 Considering the effective size to be measured (d) at 0.7, power of the study at 85% and the margin of error at 5%, the total sample size needed is 62. The total sample size is divided into two groups. Each group will consist of 31 samples (31x2 = 62 samples).

Methodology for objective 1: The average sizes of the artificial teeth will be determined based on a cross-sectional surveymeasuring the natural anterior teeth sizes amongst people aged more than 45 years old. The commonly used acrylic maxillary anterior teeth corresponding to the sizes commonly used in the institution will be selected for both the genders. These acrylic teeth are then trimmed to a thin shell measuring 1.5 mm in thickness. The sizes selected based on the survey are ArcyRock size 13,15,18 and 32; and Premadent sizes S1, M2, N2, A26. The novel esthetic strip will be formed by attaching the thin shells of acrylic to a tissue tape with a thickness of 0.05 mm.

Methodology for objective 2: The patients will be randomly divided into two groups. For one group, the novel esthetic strips will be used for teeth selection. These strips are attached to the maxillary occlusion rim during the jaw relations appointment to aid teeth selection. Multiple strips can be tried until the patient and the clinician reach a mutual agreement. For the other group of patients, the anterior maxillary teeth will be slected based on a conventional method. This involves arbitrarily selecting anterior teeth with the help of teeth mold sizes based on the width of the ala of the nose which is equivalent to the inter-canine tip distances (Attokoran et al, 2018 and Pisulkar et al, 2022).

**Methodology for objective 3:**A patient satisfaction questionnaire related to the teeth size be designed and based on a five-point Likert scale with points ranging from 0 to 4. The lowest point will indicate the worst satisfaction while the highest point will indicate the best satisfaction (0 – very dissatisfied, 1 – dissatisfied, 2 – neither dissatisfied nor satisfied, 3 – satisfied, 4 – very satisfied) (Anastassiadou et al, 2004 and Ahmed et al, 2019). The questionnaire will be filled by both the groups of patients during jaw relations and after the insertion of the dentures.

Planned statistical analyses:

Statistical package for social sciences (SPSS) for windows version 21.0 released 2021, Armonk NY, IBM Corp was used to analysis the data.

Independent sample T test will be used to compare the mean patient satisfaction scores using conventional method and novel esthetic strips after jaw relation and insertion of complete denture.

Chi square test will be applied to compare the proportions of patient satisfaction scores between using the conventional method and novel esthetic strips after Jaw relation and after insertion of the complete denture.