1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response (Others) -  Data will be made available on request by principal investigator.


6. For how long will this data be available start date provided 21-04-2023 and end date provided 21-04-2026?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

AIM:

To evaluate the effect of alteration of palatal surface of anterior teeth and palatal contour of maxillary complete denture on speech parameters.

 OBJECTIVES:

1.     To evaluate the effect of intact artificial anterior teeth on speech parameters.

2.     To evaluate the effect of modified artificial anterior teeth on speech parameters.

3.     To evaluate the effect of smooth palatal surface of complete denture on speech parameter.

4.     To evaluate the effect of anatomical palatal surface of complete denture on speech parameters.

5.     To evaluate the speech parameters in dentulous patient with intact dentition.

6.     To objectively compare the speech parameter in different groups.

 MATERIAL AND METHODS

STUDY LOCATION-

This Randomized clinical trial will be conducted in Saraswati Dental College, Lucknow in the Department of Prosthodontics And Crown And Bridge, from January 2020 to June 2022.

ETHICAL APPROVAL & TRIAL REGISTRATION-

·       Ethical approval will be taken from The Institutional Human Ethics Committee (IHEC) .

·       All enrolled participants will be fully informed about the study, and written informed consent will be obtained.

·       The trial will be prospectively registered at Clinical Trial Registry of India(ctri.gov.in)

SAMPLE SIZE ESTIMATION-

 Sample size estimation was done by using GPower software (version 3.0). Sample size was estimated for ANOVA.

A minimum total sample size of 33 was to be sufficient for an alpha of 0.05, power of 85 %, 0.87 as effect size (assessed from a similar study by Stelzle F., Kong HJ. Adaki R). Thus sample size was rounded off to 35 i.e 7 in each group.

RANDOMIZATION AND GROUP ALLOCATION-

·       Participants will be assigned to four intervention groups, by using computer generated randomization sequence to avoid allocation bias.

·       Four intervention groups are(Modified Denture Groups)

·       Group I- Dentures with anatomical palate and with cingulum.

·       Group II- Dentures with anatomical palate and without cingulum.

·       Group III- Dentures with smooth palate and with cingulum.

·       Group IV- dentures with smooth palate and without cingulum.

       One more group will be included that will be the test group.

·       Group V- dentulous patients with intact dentition.

 INCLUSION CRITERIA

1.     Edendulous patients between age group 40-70 will be included in test group.

2.     Patient with history of first time denture wear will be included in test group.

3.     Dentulous patients between age 40-70 will be included in control group.

 EXCLUSION CRITERIA-

1.     Patients with speech disturbances like tongue tie.

2.     Patients with neurological disorders.

 METHOD-

 DENTURE FABRICATION

^v   Dentures will be fabricated for all the four intervention group by conventional technique.⁹

v  In group I denture will be given with rugae incorporation on anterior palatal surface of maxilla and anterior teeth with cingulum .

v  In group II denture will be given with rugae incorporation on anterior palatal surface of maxilla and anterior teeth without cingulum.

v  In group III denture will be given with smooth palatal surface of maxilla and anterior teeth with cingulum.

v  In group IV denture will be given with smooth palatal surface of maxilla and anterior teeth without cingulum is used.

RECORDING SAMPLES FOR SPEECH ANALYSIS

v  The speech recording will be done in a sound proof room using a digital audio tape recorder and microphone.v  All the participants in the four intervention groups and control group will be asked to read out the HINDI sentences containing linguopalatal sounds at an interval of 3 sec to maintain uniform space.

v  Linguopalatal consonants will be divided in to voiceless(s, sh, th, ch, t) and voiced consonants  ( zh, j, n, l. z, d).

v  Acoustic analysis for various speech parameters will be done by using speech analysis software.

v  The variations in the intervention group and control group will be compared.

 Null Hypothesis-There will be no effect of manipulation of palatal surface of anterior teeth and anterior palatal surface of maxillary complete denture on speech parameters.