A comparative evaluation of prosthetic and biological outcome of two different implant restorative materials

Not yet recruiting

• Conditions: BILATERAL MISSING POSTERIOR TEETH; Other periodontal diseases,

• Registration Number: CTRI/2022/02/039915
• Lead Sponsor: Taniya Malhotra

Brief Summary

TITLE: A COMPARATIVE EVALUATION OFPROSTHETIC AND BIOLOGICAL OUTCOME AS INFLUENCED BY TWO DIFFERENT IMPLANTRESTORATIVE MATERIALS (PORCELAIN FUSED TO METAL AND MONOLITH ZIRCONIA)“ -  A PROSPECTIVE, CROSS ARCH STUDY



BACKGROUND: For proof of the change of material choice from metal ceramic to zirconia,clinical studies are needed which are lacking in the literature and there is alacunae regarding comparison of zirconia andmetal ceramic reconstructions in relation to implant supported restorations.



AIM: To evaluate and compare the prosthetic parameters, clinical indices, crestal bone levels and inflammatory biomarkers in peri implant crevicular fluid as influenced by twodifferent implant restorative materials (porcelain fused to metal andmonolithic zirconia) at baseline, 6 months and 1 year



METHODOLOGY: 20 patients will be selected from the outpatient department ofDepartment of Prosthodontics, Faculty of Dental Science SGT University. Second stage surgery will be performed and healing abutments will beplaced for one week. After one-week healing caps will be removed andfinal impression will be made using closed or open tray impression techniqueusing polyether impression material. Alginate will be usedfor the impression of the opposing jaw, and silicone will be applied for thebite registration. All crowns will be fabricated by one experienced masterdental technician. Mono-ZrO2 crowns will be fabricated using a laboratory-basedCAD and an industrial CAM process. For the PFM group, conventional model willbe used for the fabrication of the PFM crown. The conventional manufacturingwill include the lost-wax technique for the casting of the base metal corefollowed by manual layering of the veneering ceramic followed by ceramic firingaccording to the manufacturers’ instructions. the crowns will be adjusted inthe mouth and polished or glazed after which they will be cleaned with ethanolsolution and cemented with resin cement. the access hole will be blocked usingflowable composite resin.

Immediately following cementation of therestorations clinical status using modified USPHS criteria and periodontalstatus around the implant restored with porcelain fused to metal, implantrestored with zirconia and the natural teeth in the same arch will be recordedby applying the following clinical indices i.e. bleeding on probing, plaqueindex, probing depth and width of keratinized gingiva. For the indices andmeasurement of probing depth a Williams probe will be used. The examinationwill involve the use of a thin periodontal probe with Williams marking (at 1,2, 3, 5, 7, 8, 9, and 10 mm), the entire sulcus of the restored implant and thecontrol tooth will be probed, and a reading will be taken.

The total technical complication rate on theprosthetic level (primary outcome) will include fracture of the veneeringceramic, fracture of the crown, fracture of the abutment, fracture of theabutment screw, loosening of the abutment screw, loss of the occlusal filling, anddecementation.

Crestal bone levels will be measured using RVG

Inflammatory markers in the PICF will be measured using ELISA.

Statistical Analysis: Resulting data will be analyzed statistically.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-02
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1.Two implants placed in the same arch in posterior quadrant requiring prosthodontic rehabilitation.
• 2.Interocclusal restorative space of 8-10 mm 3.Healthy Periodontium with no visible signs of bruxism 4.Stable and healthy implants with no crestal bone loss.

Exclusion Criteria

• According to ASA Classification Class 4 patients: Organic heart disease with marked signs of cardiac insufficiency Recent myocardial infarction of less than 6 months duration.
• Unstable angina.
• Patients with advanced degrees of pulmonary, renal or endocrine insufficiency 2.
• According to ASA Classification Class 3 patients Diabetes with complications to vascular or other organs, i.e., retinopathy, neuropathy, etc.
• Occlusal anomalies Deep Bite Cross Bite 4.
• Long term edentulism leading to mesial drifting of adjacent teeth or supraaeruption of opposing teeth 5.Para-functional Habits (Bruxism) 6.Smokers 7.Active periodontal disease 8.Allergy to materials used in the study 9.Current drug abuse 10.Pregnant or intend to become pregnant.
• 11.Severe salivary gland dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary outcome will determine which restoration will be more suitable for implant supported prosthesis.	primary outcome will determined at baseline, 6 months and 12 months
The suitabilty of the restorations will depend on the prosthetic and biologic outcome which will include ceramic fracture, screw loosening, marginal fit, color match, occlusal wear, bleeding on probing, plaque deposition etc	primary outcome will determined at baseline, 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
To Determine the biological outcome through evaluation of inflammatory markers of two different implant restorative materials. The inflammatory marker to be evaluated is MMP-8.	Biological outcome will be assessed at baseline, 6 months and 12 months

Trial Locations

Locations (1)

SGT University; 🇮🇳 Gurgaon, HARYANA, India

SGT University

🇮🇳Gurgaon, HARYANA, India

Taniya Malhotra

Principal investigator

9560886370

taniyamalhotra08@gmail.com