Hyaluronic Acid (HA)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 study testing commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental Restorations in people with Hyaluronic Acid (HA), run by Cairo University.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyaluronic Acid (HA)
- What is being tested?
- commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental Restorations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Smoking habits
- Pregnant and lactating mothers
- Patients who have been received periodontal surgery in the study area during the last 6 months
About this study
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)
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).
Read the detailed description
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
- Conditions
- Hyaluronic Acid (HA)
- Being tested
- commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental Restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental RestorationsProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Study Group | Experimental | Group (A and B): 3D Printed Dental Restoration with hyaluronic acid and Milled CAD CAM Dental Restoration with hyaluronic acid. Receives: Procedure: commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental Restorations |
| Control Group | Active comparator | Group (C and D): 3D Printed Dental Restoration without hyaluronic acid and Milled CAD CAM Dental Restoration without hyaluronic acid Receives: Procedure: commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental Restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Loss (CAL)
- will be measured clinically using UNC periodontal probe from cemento enamel junction to depth of periodontal pocket
Measured: 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%
Measured: 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
Measured: Day 0 - month 3
Secondary outcomes (2)
biocompatibility
- will be calculated through measuring Bop, gingival index, and plaque index as mentioned before.
Measured: 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.
Measured: Day 0 - month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaluronic Acid (HA)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Helal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625839
- Sponsor's protocol ID
- 15022026
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07625839
- Acronym / sponsor ID
- 15022026
- Conditions
- Hyaluronic Acid (HA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Clinical attachment loss (CAL)
- Plaque Index (PI)
- Gingival Index (GI)
- Bleeding on probing (BOP)
- using digital scanner then a profilometer to measure surface roughness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Study Group | Experimental | Procedure: commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental RestorationsGroup (A and B): 3D Printed Dental Restoration with hyaluronic acid and Milled CAD CAM Dental Restoration with hyaluronic acid. |
| Control Group | Active comparator | Procedure: commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental RestorationsGroup (C and D): 3D Printed Dental Restoration without hyaluronic acid and Milled CAD CAM Dental Restoration without hyaluronic acid |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Systemic healthy patients
Key exclusion criteria (3 listed)
- Smoking habits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Control Group, Intervention Study Group |
Primary outcome
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
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%
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. 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
2 secondary outcomes
biocompatibility
Time frame: Day 0 - month 3
Surface roughness
Time frame: Day 0 - month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing commonly used hyaluronic Acid with both procedures 3D Printed Versus Milled CAD CAM Provisional Dental Restorations in people with Hyaluronic Acid (HA), run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Loss (CAL) (time frame: Day 0 - month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.