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 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)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Hyaluronic Acid (HA)
• Intervention / Treatment: Procedure: commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental Restorations

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Study Group; Group (A and B): 3D Printed Dental Restoration with hyaluronic acid and Milled CAD CAM Dental Restoration with hyaluronic acid.	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
Active Comparator: Control Group; Group (C and D): 3D Printed Dental Restoration without hyaluronic acid and Milled CAD CAM Dental Restoration without hyaluronic acid	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment Loss (CAL)	• will be measured clinically using UNC periodontal probe from cemento enamel junction to depth of periodontal pocket	Day 0 - month 3
bleeding on probing (BOP)	will be measured clinically using UNC periodontal probe. Count the bleeding points and divided them by the total number of patients' teeth in the oral cavity and multiply by 100 to make the percent. localized less than 30% and generalized greater than or equal 30%	Day 0 - month 3
Plaque index (PI)	plaque index This clinical method assesses the thickness of plaque specifically at the cervical margin (gumline). The Scoring Scale (0 to 3): 0: No plaque in the gingival area.; A film of plaque visible only by running a probe across the tooth surface or after using a disclosing solution.; Moderate accumulation of plaque visible to the naked eye along the gumline.; Abundance of soft matter within the pocket or along the gumline	Day 0 - month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biocompatibility	• will be calculated through measuring Bop, gingival index, and plaque index as mentioned before.	Day 0 - month 3
Surface roughness	will be measured using a surface roughness measuring instrument (or profilometer) is a precision device used to evaluate the texture of a material by measuring microscopic peaks and valleys. They are essential for quality control in manufacturing to ensure components meet strict friction, wear, and coating adhesion standards.	Day 0 - month 3

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 15022026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No