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NCT Number: NCT07625839

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).

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Key information

Conditions

Hyaluronic Acid (HA)

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

  • Clinical attachment loss (CAL)
  • Plaque Index (PI)
  • Gingival Index (GI)
  • Bleeding on probing (BOP)
  • using digital scanner then a profilometer to measure surface roughness

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental Restorations

Procedure
  • 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 outcomes

  1. Clinical Attachment Loss (CAL)

    Time frame: Day 0 - month 3

    • will be measured clinically using UNC periodontal probe from cemento enamel junction to depth of periodontal pocket

  2. bleeding on probing (BOP)

    Time frame: Day 0 - month 3

    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%

  3. Plaque index (PI)

    Time frame: Day 0 - month 3

    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

Secondary outcomes

  1. biocompatibility

    Time frame: Day 0 - month 3

    • will be calculated through measuring Bop, gingival index, and plaque index as mentioned before.

  2. Surface roughness

    Time frame: Day 0 - month 3

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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