Enamel caries is a progressive subsurface demineralisation ultimately resulting in mechanical failure and cavitation. For “early†carious lesions, the currently used treatment protocol include sealing carious lesions (sealants and resin infiltration), and remineralization procedures mainly with fluorides or using CPP-ACP ,to determine whether or not the lesion will progress, in which case a restoration would then be placed When the ph of saliva is critically low at 5.5 the presence of additional extrinsic sources of stabilized Ca2+ and PO43– ions could augment the natural remineralization potential of saliva by increasing diffusion gradients favouring faster and deeper subsurface remineralization. The shift from repairative to regenerative dentistry reflects the current trend in medicine wherein diseased dental tissues are replaced with biologically similar tissues Enamel regeneration is however particularly challenging as mature enamel is acellular and does not resorb or remodel itself unlike bone or dentin. Advances in tissue engineering methods have yielded biomimetic methods that have demonstrated a strong potential for regenerating the hierarchical enamel microstructure. The novel rationally designed self-assembling P11-4 peptide,consisting of 11 amino acids can be used for regenerating demineralized tooth tissue . This low viscosity isotropic P11-4 when applied on the initial carious lesion rapidly diffuses into the lesion body, where it transforms to an elastomeric nematic gel in the presence of cations and pH < 7.4, leading to the 3-dimensional fibre matrix assembly ,which enables de novo hydroxyapatite crystal formation facilitating the guided enamel regeneration of the lost enamel structure. Aim of the study is To compare the combinatory effects of novel self assesmbling p11-4 peptide and nanohydroxyapatite with that of nanohydroxyapatite alone on remineralization efficacy of early buccal carious lesions. OBJECTIVES OF THE STUDY To assess the remineralization efficacy following a single application of P11-4 and nanohydroxyapatite mixture on early buccal surface enamel lesions. To assess the remineralization efficacy following application of nanohydroxyapatite alone on early buccal surface lesions. To compare the p11-4 peptide – nanohydroxyapatite mixture with that of nanohydroxyapatite alone on the basis of remineralization efficacy. SOURCE OF SUBJECTS: 40 outpatients attending the Department of Conservative Dentistry and Endodontics from Vokkaligara Sangha Dental College, Bangalore, who will have volunteered to participate will be included in the study. MATERIALS INCLUDED IN THE STUDY P 11 -4 PEPTIDE nanohydroxyapatite Prophylaxis paste. Etching agent. Sterile water. Applicator tip. Micromotor. Exploratory probe. Digital camera. Rubber dam kit BASELINE ASSESSMENT: A general oral and physical examination including a dental, medical and social history. A series of digital colour photographs of the test lesion taken under standard conditions of light and magnification. A detailed relevant medical (including dental) history covering the previous three years and a medication they were taking at the time of the study. PROCEDURE FOR APPLICATION OF P11-4 PEPTIDE After recording preoperative condition, isolation is achieved using rubber dam. The superficial pellicle is removed by using a prophylaxis paste such as pumice, followed by application of 35% phosphoric acid for 30 s. After cleaning and drying surface is assessed for open pores to allow the material to penetrate the lesion and initiate the process.
Lyophilized p11-4 peptide is rehydrated with 0.05 ml of sterile water and a single drop of the resulting solution is immediately applied on the lesion for approximately 5mins ensuring moisture control.10% aqueous slurry of nanohydroxyapatite is applied and left undisturbed for 3 mins. For the control group the same procedure is repeated adding nanohydroxyapatite alone FOLLOW UP The patient will be assessed and evaluated at baseline,1, 3 & 6 months after treatment using standard digital photographs, Nyvad score. ASSESMENT OF THE LESION: A series of colour photographs of the test lesion is taken under standard conditions of light and magnification to asses lesion size, appearance and progression. A chart and professional photographs is made for each patient for follow up and scoring of the white spot lesions at different time periods. The clinical photographs are processed using photographic editing software (Adobe Photoshop 7.0, Adobe Systems Inc., San Jose, California, USA), then the stained area is calculated as % of the total teeth area by the following equatio The data is subjected to analysis at baseline, 3 and 6 months respectively.
SCORING CRITERIA – NYVAD SCORING CRITERIA | Score | CATEGORY | CRITERIA | | 0 | Sound | Normal enamel translucency & texture(slight staining allowed in otherwise sound fissure) | | 1 | Active caries (intact surface) | Surface of enamel is white/ yellowish opaque with loss of lustre; feels rough when the tip of the probe is moved gently across the surface ;generally covered with plaque. No clinically detectable loss of substance. Smooth surface; carious lesions typically located near the gingival margin. Fissure/pit: intact: lesion extending along the walls of the fissure, | | 2 | Active caries (surface discontinuity) | Same criteria as score 1 Localized surface defect( microcavity) in enamel only. No undermined enamel or softened floor detectable with the explorer. | | 3 | Active caries (cavity) | Enamel/dentin cavity easily visible with the naked eye: surface of cavity feels soft or leathery on gentle probing There may or may not be pulpal involvement. | | 4 | Inactive caries (intact surface0 | Surface of enamel is whitish, brownish or black Enamel may be shiny and feels hard and smooth when the tip of the probe is moved gently across the surface no clinically detectable loss of substance Smooth surface caries lesion typically located at some distance from gingival margin Fissure/pit:intact fssure morphology: lesion extending along, the walls of the fissure | | 5 | Inactive caries (surface discontinuity) | Same criteria as score -Localized surface detect (microcavity, in enamel only No undermined enamel or softened floor detectable with the explorer. | | | 6 | Inctive caries (cavity) | Enamel /dentin cavity easilv visible with the naked eye, surface of cavity mav be shinv and feels hard on probing with gentle pressure. No pulpal involvement | | | 7 | Filling (sound surface) | | | | 8 | Filling + active caries | Caries lesion may be cavitated or non cavitated. | | | 9 | Filling + inactive caries | Caries lesion may be cavitated or non cavitated. | | ANALYSIS OF DATA Statistical
Package for Social Sciences [SPSS] for Windows Version 22.0 Released 2013.
Armonk, NY: IBM Corp., will be used to perform statistical analyses. Descriptive
Statistics: Descriptive
analysis of all the explanatory and outcome parameters will be done using mean
and standard deviation for quantitative variables, frequency and proportions
for categorical variables. Inferential
Statistics: Chi
Square Test will be used to compare the Nyvad criteria for assessment for the
Buccal Lesions & Success Rate treated between biomimetic self-assembling
peptide P11-4-nanohydroxyapatite mixture with that of nanohydroxyapatite alone at
3 & 6 Months’ post follow-up period. Marginal
Homogeneity test will be used to compare the Nyvad criteria for assessment for
the Buccal Lesions between 3 & 6 Months’ post follow-up period in each
study group. McNemar’s
test will be used to compare the mean success rate of remineralization of
buccal lesions between 3 & 6 Months’ post follow-up period in each study
group. The
level of significance will be set at P<0.05.
And any other relevant test, if
found appropriate during the time of data analysis will be dealt accordingly. |