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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)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07625839
Enrollment
60
Registered
2026-06-04
Start date
2026-06-01
Completion date
2026-08-01
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyaluronic Acid (HA)

Brief summary

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

PROCEDUREcommonly 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Attachment Loss (CAL)Day 0 - month 3• will be measured clinically using UNC periodontal probe from cemento enamel junction to depth of periodontal pocket
bleeding on probing (BOP)Day 0 - month 3will 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%
Plaque index (PI)Day 0 - month 3plaque 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. 1. A film of plaque visible only by running a probe across the tooth surface or after using a disclosing solution. 2. Moderate accumulation of plaque visible to the naked eye along the gumline. 3. Abundance of soft matter within the pocket or along the gumline

Secondary

MeasureTime frameDescription
biocompatibilityDay 0 - month 3• will be calculated through measuring Bop, gingival index, and plaque index as mentioned before.
Surface roughnessDay 0 - month 3will 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026