Study On The Performance Of The Tooth Jewel.

Not yet recruiting

Conditions: Healthy Human volunteers willing to get a tooth jewel for enhancing their smile.

Registration Number: CTRI/2018/12/016573

Lead Sponsor: Dr Purabi Edbor

Brief Summary: INTRODUCTION :

Aesthetics has become an important aspect of dentistry overthe past few years and has led to the development of newer materials andtechniques. Today people ,especially adolescents are becoming increasingly selfconscious about their appearance and are trying various forms of body art. Onesuch cosmetic procedure to add a spark to their smile is Tooth Jewellery. Toothjewellery is a cosmetic dental procedure where a diamond or a stone is attachedto the surface of the teeth .

There is a scarcityof data regarding the clinical performance of tooth jewellery currently .Thisclinical trial will be evaluating and comparing the longevity of tooth jewel inthe oral cavity. It will also throw some light on marginal discoloration andintegrity of the flowable composites that will be used to fix the jewel on thesurface of the teeth.

PRIMARY RESEARCH QUESTION : To assess and compare theclinical performance of tooth jewel luted with three commercially availableflowable composites in young adults .

STUDY DESIGN : Randomised Controlled Trial .

STUDY SETTING : Department of Conservative Dentistry andEndodontics.

STUDY POPULATION : Adult population belonging to the agegroup of18-35 years in Central India as per the inclusion and exclusioncriteria.

SAMPLE SIZE : N = 75

n = 25 ( 25 in each group)

PROCEDURE : Approval from the Institutional EthicalCommittee will be obtained.

Self motivated patients from the adult population will beselected for the study.

Participants will be randomly assigned to one of the threegroups using computer generated numbers.

Written informed consent will be taken from the patient.

- The tooth will be cleaned with a fluoride-free polishingpaste.

- The tooth will be completely dried and isolated.

- Tooth will be etched with 3M Espe Scotchbond Etchant forabout 20-30 seconds.

- The surface will be rinsed thoroughly with water and blowdried for 10 seconds.

- A light-cure bonding agent (3M Espe AdperScotchbondMultipurpose plus) will be applied , left for a maximum of 20 seconds .

- Then it will be light-cured for 20 sec.

- A small amount of respective flowable composite will beapplied to the labial

surface of the tooth.

- Jewel will be picked up and pressed into the centre ofcomposite.

- Slight adjustment of the jewel positioning will be done.

- Curing of composite will be done from the top for about 60seconds, from the sides for a few seconds and from the back for another 60seconds making sure the composite hardens evenly.

- Total curing time will be approximately 180 seconds.

- The total time for jewel to set into the composite is 20sec.

- It will take about 4 minutes to safely affix the jewel.

- Pre and post procedural photographs will be taken.

- Post operative instructions will be given.

- The patient will be recalled after 1 month, 3 months and 6months for clinical evaluation regarding marginal integrity, discolouration offlowable composites and longevity of tooth jewel.

- Post-operative evaluation will be carried out using theModified United States Public Health Service (USPHS) Ryge criteria.

RESULTS : Awaited.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

Patients belonging to age group of 18-35 years .
Self motivated patients who are interested in getting a tooth jewel to enhance their smile.
Caries free oral cavity.
Sound canine.
Patient not having a traumatic bite.
Patients not having any prosthesis associated with the canine.

Exclusion Criteria

Patients with high caries index.
Carious canine.
Prosthesis with canine.
Traumatic bite.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the clinical performance ( Marginal integrity , marginal discolouration and retention )of tooth	1st month , 3rd month and 6th month.
jewel luted with three commercially available flowable composites	1st month , 3rd month and 6th month.

Secondary Outcome Measures

Name	Time	Method
To assess and compare the marginal integrity and marginal discolouration associated with the three commercially available flowable composites used for luting the tooth jewel .	1st month , 3rd month and 6th month.

Trial Locations

Locations (1): VSPM Dental College & Research Centre .
🇮🇳
Nagpur, MAHARASHTRA, India
VSPM Dental College & Research Centre .
🇮🇳Nagpur, MAHARASHTRA, India
Dr Purabi Edbor
Principal investigator
7038917303
purabiedbor@gmail.com