A Comparative Clinical Assessment of Adjunctive Hyaluronic Acid With 3D Printed Versus Milled CAD CAM Provisional Dental Restorations on Active Periodontal Status and Surface Roughness and Biocompatibility

Official title

A Comparative Clinical Assessment of Adjunctive Hyaluronic Acid With 3D Printed Versus Milled CAD CAM Provisional Dental Restorations on Active Periodontal Status and Surface Roughness and Biocompatibility (A Randomized Controlled Clinical Trial)

Overview

A Comparative Clinical Assessment of Adjunctive Hyaluronic Acid with 3D Printed Versus Milled CAD CAM Provisional Dental Restorations on active Periodontal status and Surface Roughness and biocompatibility (A Randomized Controlled clinical Trial).

Detailed description

This randomized clinical trial evaluates their effects regarding periodontal assessment, including

1. Clinical attachment loss (CAL) 2. Plaque Index (PI) 3. Gingival Index (GI) 4. Bleeding on probing (BOP) 5. using digital scanner then a profilometer to measure surface roughness

Interventions

• Procedure commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental Restorations
  * Tooth preparation will be performed following standardized prosthodontic guidelines * 1.5-2 mm occlusal reduction * 1-1.2 mm axial reduction * Chamfer finish line * Digital impressions will be obtained using an intraoral scanner. * CAD/CAM Milled and 3D printed Provisionals will be fabricated * Once the study restorations were finished, the intraoral optical impression was made. While control both procedures will be done but without using hyaluronic acid

Primary outcome measures

• Clinical Attachment Loss (CAL) [Time frame: Day 0 - month 3]
• bleeding on probing (BOP) [Time frame: Day 0 - month 3]
• Plaque index (PI) [Time frame: Day 0 - month 3]

Secondary outcome measures (2)

• biocompatibility [Time frame: Day 0 - month 3]
• Surface roughness [Time frame: Day 0 - month 3]

Eligibility criteria

Inclusion criteria

• Systemic healthy patients

• Patients aged > 25 years
• Patients suffering from stage II periodontitis with grade B were included in this study, according to 2017 world workshop classification of periodontal disease (Papapanou et al. 2017).
• Patients with interdental clinical attachment loss (CAL) of 3-4 mm
• No history of previous periodontal therapy.
• No taken medications known to interfere healing or periodontal tissue health such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs.
• No previous periodontal surgery at involved sites.
• Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
• Neither taken antibiotics within the last three months nor nonsteroidal anti-inflammatory drugs within the last three months
• Absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders
• Absence of oral mucosal inflammatory conditions such as aphthous ulcers or lichen planus.

Exclusion criteria

• Smoking habits

• Pregnant and lactating mothers
• Patients who have been received periodontal surgery in the study area during the last 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07625839 · 15022026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗