Peri-implant Soft Tissue HealingNCT07287722
Soft Tissue Response and IL-1β Levels Around CAD/CAM-Milled vs 3D-Printed PMMA Healing Abutments
A study testing CAD/CAM-Milled PMMA Healing Abutment and 3D-Printed PMMA Healing Abutment in people with Peri-implant Soft Tissue Healing, run by Ali Hassan Eid Toto at 1 site in Egypt.
Trial summary
This study looked at how the gums and tissues around dental implants heal when using two different types of temporary healing caps made of PMMA (a common dental material). These healing caps help shape the gums before placing the final crown. There are two ways to make these caps: 1. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Soft Tissue Healing
- What is being tested?
- CAD/CAM-Milled PMMA Healing Abutment and 3D-Printed PMMA Healing Abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Nov 2025to 23 Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 25 to 65 years
- Presence of one osseointegrated dental implant placed at least 8 weeks prior to second-stage surgery
- Adequate zone of attached keratinized gingiva (> 1 mm) around the implant site
- Good general health and able to provide informed consent
- Willing and able to attend all follow-up visits (1, 2, and 4 weeks)
Who cannot join
- Smoking more than 20 cigarettes per day
- Presence of systemic diseases that may affect healing (e.g., autoimmune conditions, uncontrolled diabetes, immunosuppressive disorders)
- Oral inflammatory conditions or active oral infections
- History of head and neck radiation therapy or chemotherapy
- Use of corticosteroids or antibiotics within the last 3 months
- Parafunctional habits (e.g., bruxism)
- Pregnant or breastfeeding individuals
- Implants with insufficient attached gingiva or poor oral hygiene maintenance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Biochemical Assessment of the Soft Tissue Response to Printed Versus Milled Polymethyl Methacrylate Custom Healing Abutments
This study looked at how the gums and tissues around dental implants heal when using two different types of temporary healing caps made of PMMA (a common dental material). These healing caps help shape the gums before placing the final crown.
There are two ways to make these caps:
Read more
- CAD/CAM-milled (carved from a solid block)
- 3D-printed (built layer by layer using resin) The goal was to find out which type leads to healthier gum tissue. What the Researchers Did
- 22 dental implants in 22 patients were included.
- Each implant received one healing cap-either milled or 3D-printed.
- Patients were checked after 1 week, 2 weeks, and 4 weeks.
- The team measured:
- Gum inflammation
- Bleeding around the implant
- Plaque buildup
- Pocket depth around the implant
- Levels of an inflammatory marker called Interleukin-1β (IL-1β) in the gum fluid (higher levels mean more inflammation).
- Surface smoothness and material quality of each type of healing cap. What the Study Found
- Gum inflammation and bleeding were higher with 3D-printed caps, especially at week 4.
- IL-1β levels were much higher around 3D-printed caps-showing more inflammation.
- Both types had some increase in plaque and probing depth over time, but there was no major difference between groups.
- The milled caps had smoother surfaces and better material quality, which may have helped reduce irritation and inflammation.
- 3D-printed caps were rougher and had lower polymerization (more leftover monomers), which may trigger soft-tissue irritation.
What This Means
- CAD/CAM-milled PMMA healing caps appear to be safer and healthier for gum healing around dental implants.
- They may help reduce early inflammation, support better tissue health, and more predictably shape the gums during healing.
Why This Matters for Patients
- Using a smoother, better-finished healing cap may lower the risk of early gum inflammation.
- Healthier soft tissue around an implant leads to better long-term implant stability.
- This information can help dentists choose the best healing cap for optimal healing.
Study Timeframe
- The follow-up was 4 weeks, so results focus on early healing. More research is needed to know long-term differences.
- Conditions
- Peri-implant Soft Tissue Healing
- Being tested
- CAD/CAM-Milled PMMA Healing Abutment, 3D-Printed PMMA Healing Abutment
- Keywords
- Dental implants, Healing abutments, PMMA, CAD/CAM milled abutments, 3D-printed abutments, Peri-implant soft tissue, Peri-implant inflammation, Interleukin-1 beta (IL-1β), Peri-implant crevicular fluid, Surface roughness, Degree of conversion, Biocompatibility, Digital dentistry, Soft tissue healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM-Milled PMMA Healing AbutmentDevice
A customized healing abutment fabricated by subtractive CAD/CAM milling from a pre-polymerized PMMA block. Milling produces a highly polished, low-porosity surface with a high degree of polymerization. The abutment is connected to a Ti-base and placed at second-stage surgery to shape peri-implant soft tissues.
3D-Printed PMMA Healing AbutmentDevice
A customized healing abutment produced by additive manufacturing (3D printing) using a light-cured PMMA resin. The abutment is printed layer-by-layer, washed in isopropyl alcohol, UV-cured, finished, and polished. This manufacturing technique results in a different surface texture and polymerization level compared to milled PMMA. The abutment is attached to a Ti-base and placed at second-stage surgery.
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM-Milled PMMA Healing Abutment | Experimental | Participants receive a customized PMMA healing abutment manufactured using CAD/CAM milling from a pre-polymerized PMMA block. The abutment is attached to the implant at second-stage surgery to guide soft-tissue healing. Receives: Device: CAD/CAM-Milled PMMA Healing Abutment |
| 3D-Printed PMMA Healing Abutment | Experimental | Participants receive a customized PMMA healing abutment manufactured using 3D printing from a light-cured PMMA resin, followed by post-processing and UV curing. The abutment is attached to the implant at second-stage surgery. Receives: Device: 3D-Printed PMMA Healing Abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-1β (IL-1β) Level in Peri-Implant Crevicular Fluid
Concentration of IL-1β in peri-implant crevicular fluid collected using sterile paper points. Samples are stored at -80°C and analyzed using ELISA kits. Higher IL-1β levels indicate greater inflammatory response. Mean IL-1β values are compared between CAD/CAM-milled and 3D-printed PMMA healing abutment groups at each time point.
Measured: up to 4 weeks
Secondary outcomes (6)
Modified Gingival Index (MGI)
Soft-tissue inflammation around the healing abutment assessed using the Modified Gingival Index (0-3 scale) at four peri-implant sites (mesial, distal, buccal, palatal). Higher scores indicate more severe inflammation. Group differences and changes over time are evaluated.
Measured: up to 4 weeks
Plaque Index (PI)
Plaque accumulation measured at four implant surfaces using a 0-3 scale (0 = no plaque; 3 = heavy soft deposits). Mean PI values are compared between study groups and across time points.
Measured: up to 4 weeks
Bleeding on Probing (BOP)
Presence or absence of bleeding upon gentle probing around the healing abutment. BOP is recorded as a binary variable and expressed as the percentage of implants with bleeding in each group.
Measured: up to 4 weeks
Probing Pocket Depth (PPD)
Probing depth in millimeters measured at four peri-implant sites using a plastic periodontal probe. Mean pocket depths and changes over time are compared between groups.
Measured: up to 4 weeks
Surface Roughness of PMMA Healing Abutments
Surface roughness parameters (Ra, Rz, Rp, Rv) measured via profilometry for CAD/CAM-milled and 3D-printed PMMA abutments. Higher values indicate rougher surfaces. Group means are compared.
Measured: Immediately after fabrication
Degree of Conversion (%) of PMMA Material
Degree of polymerization of PMMA material measured using spectroscopic methods. Higher percentages indicate more complete polymerization and lower residual monomer content. Compared between milled and 3D-printed groups.
Measured: Immediately after fabrication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start23 Nov 2025
- Primary completion23 Dec 2025 (estimated)
- Study completion23 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Soft Tissue HealingStudies of the same condition, open and under way.
- 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
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel groups. Each participant receives only one type of healing abutment either a CAD/CAM-milled PMMA abutment or a 3D-printed PMMA abutment at the time of second-stage implant surgery and remains in that assigned group throughout the 4-week follow-up period. No crossover occurs between groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali Hassan Eid Toto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Hassan Eid Toto, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287722
- Sponsor's protocol ID
- AlexandriaUali
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Assessment of the Soft Tissue Response to Printed Versus Milled Polymethyl Methacrylate Custom Healing Abutments
- ClinicalTrials.gov ID
- NCT07287722
- Acronym / sponsor ID
- AlexandriaUali
- Conditions
- Peri-implant Soft Tissue Healing
- Keywords
- Dental implants, Healing abutments, PMMA, CAD/CAM milled abutments, 3D-printed abutments, Peri-implant soft tissue, Peri-implant inflammation, Interleukin-1 beta (IL-1β)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ali Hassan Eid TotoUniversity, hospital or other
- Study start
- 23 Nov 2025 (actual)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 17 Dec 2025 (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.
This study looked at how the gums and tissues around dental implants heal when using two different types of temporary healing caps made of PMMA (a common dental material). These healing caps help shape the gums before placing the final crown.
There are two ways to make these caps:
- CAD/CAM-milled (carved from a solid block)
- 3D-printed (built layer by layer using resin) The goal was to find out which type leads to healthier gum tissue. What the Researchers Did
- 22 dental implants in 22 patients were included.
- Each implant received one healing cap-either milled or 3D-printed.
- Patients were checked after 1 week, 2 weeks, and 4 weeks.
- The team measured:
- Gum inflammation
- Bleeding around the implant
- Plaque buildup
- Pocket depth around the implant
- Levels of an inflammatory marker called Interleukin-1β (IL-1β) in the gum fluid (higher levels mean more inflammation).
- Surface smoothness and material quality of each type of healing cap. What the Study Found
- Gum inflammation and bleeding were higher with 3D-printed caps, especially at week 4.
- IL-1β levels were much higher around 3D-printed caps-showing more inflammation.
- Both types had some increase in plaque and probing depth over time, but there was no major difference between groups.
- The milled caps had smoother surfaces and better material quality, which may have helped reduce irritation and inflammation.
- 3D-printed caps were rougher and had lower polymerization (more leftover monomers), which may trigger soft-tissue irritation.
What This Means
- CAD/CAM-milled PMMA healing caps appear to be safer and healthier for gum healing around dental implants.
- They may help reduce early inflammation, support better tissue health, and more predictably shape the gums during healing.
Why This Matters for Patients
- Using a smoother, better-finished healing cap may lower the risk of early gum inflammation.
- Healthier soft tissue around an implant leads to better long-term implant stability.
- This information can help dentists choose the best healing cap for optimal healing.
Study Timeframe
- The follow-up was 4 weeks, so results focus on early healing. More research is needed to know long-term differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel groups. Each participant receives only one type of healing abutment either a CAD/CAM-milled PMMA abutment or a 3D-printed PMMA abutment at the time of second-stage implant surgery and remains in that assigned group throughout the 4-week follow-up period. No crossover occurs between groups.
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM-Milled PMMA Healing Abutment | Experimental | Device: CAD/CAM-Milled PMMA Healing AbutmentParticipants receive a customized PMMA healing abutment manufactured using CAD/CAM milling from a pre-polymerized PMMA block. The abutment is attached to the implant at second-stage surgery to guide soft-tissue healing. |
| 3D-Printed PMMA Healing Abutment | Experimental | Device: 3D-Printed PMMA Healing AbutmentParticipants receive a customized PMMA healing abutment manufactured using 3D printing from a light-cured PMMA resin, followed by post-processing and UV curing. The abutment is attached to the implant at second-stage surgery. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 25 to 65 years
- Presence of one osseointegrated dental implant placed at least 8 weeks prior to second-stage surgery
- Adequate zone of attached keratinized gingiva (> 1 mm) around the implant site
- Good general health and able to provide informed consent
- Willing and able to attend all follow-up visits (1, 2, and 4 weeks)
Key exclusion criteria (8 listed)
- Smoking more than 20 cigarettes per day
- Presence of systemic diseases that may affect healing (e.g., autoimmune conditions, uncontrolled diabetes, immunosuppressive disorders)
- Oral inflammatory conditions or active oral infections
- History of head and neck radiation therapy or chemotherapy
- Use of corticosteroids or antibiotics within the last 3 months
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 |
|---|---|---|
| CAD/CAM-Milled PMMA Healing AbutmentA customized healing abutment fabricated by subtractive CAD/CAM milling from a pre-polymerized PMMA block. Milling produces a highly polished, low-porosity surface with a high degree of polymerization. The abutment is connected to a Ti-base and placed at second-stage surgery to shape peri-implant soft tissues. | Device | CAD/CAM-Milled PMMA Healing Abutment |
| 3D-Printed PMMA Healing AbutmentA customized healing abutment produced by additive manufacturing (3D printing) using a light-cured PMMA resin. The abutment is printed layer-by-layer, washed in isopropyl alcohol, UV-cured, finished, and polished. This manufacturing technique results in a different surface texture and polymerization level compared to milled PMMA. The abutment is attached to a Ti-base and placed at second-stage surgery. | Device | 3D-Printed PMMA Healing Abutment |
Primary outcome
Interleukin-1β (IL-1β) Level in Peri-Implant Crevicular Fluid
Time frame: up to 4 weeks
Concentration of IL-1β in peri-implant crevicular fluid collected using sterile paper points. Samples are stored at -80°C and analyzed using ELISA kits. Higher IL-1β levels indicate greater inflammatory response. Mean IL-1β values are compared between CAD/CAM-milled and 3D-printed PMMA healing abutment groups at each time point.
6 secondary outcomes
Modified Gingival Index (MGI)
Time frame: up to 4 weeks
Plaque Index (PI)
Time frame: up to 4 weeks
Bleeding on Probing (BOP)
Time frame: up to 4 weeks
Probing Pocket Depth (PPD)
Time frame: up to 4 weeks
Surface Roughness of PMMA Healing Abutments
Time frame: Immediately after fabrication
Degree of Conversion (%) of PMMA Material
Time frame: Immediately after fabrication
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 17 Dec 2025.
- Individual participant dataSharing planned: No
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Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM-Milled PMMA Healing Abutment and 3D-Printed PMMA Healing Abutment in people with Peri-implant Soft Tissue Healing, run by Ali Hassan Eid Toto at 1 site in Egypt.
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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Interleukin-1β (IL-1β) Level in Peri-Implant Crevicular Fluid (time frame: up to 4 weeks). 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 17 Dec 2025.