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Soft Tissue Response and IL-1β Levels Around CAD/CAM-Milled vs 3D-Printed PMMA Healing Abutments

NCT07287722 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-12-17

No results posted yet for this study

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. CAD/CAM-milled (carved from a solid block)
2. 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

Interventions

DEVICE

CAD/CAM-Milled PMMA Healing Abutment

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.

DEVICE

3D-Printed PMMA Healing Abutment

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.

Sponsors & Collaborators

  • Ali Hassan Eid Toto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-23
Primary Completion
2025-12-23
Completion
2025-12-23

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07287722 on ClinicalTrials.gov