ImplantNCT07697066
Different Customized Healing Abutment Materials on Peri-Implant Soft Tissue Profile
A study testing Titanium healing abutment, Polyetheretherketone (PEEK) and 3D-printed hybrid resin (P crownV4) in people with Implant and Healing, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to estimate the impact of various customized healing abutments materials on the peri-implant soft tissue profile Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Implant, Healing, Polyether Ether Ether Ketone
- What is being tested?
- Titanium healing abutment, Polyetheretherketone (PEEK) and 3D-printed hybrid resin (P crownV4)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 4 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient's aged 25-45 years old
- Patients with missing tooth needing solitary implant placement rehabilitation in the maxillary anterior regions with neighboring and opposite normal teeth.
- Adequate mesial, distal, and interocclusal space for implant engagement and its absolute re-establishment.
- Patients can recite and mark the informed approval paper.
- Medically free patients or with controlled systemic disease.
- Patients with acceptable bone quality and quantity.
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- Patients can return for follow-up examinations and evaluation.
- Patients with good oral hygiene.
- Nasal floor clearance from root apex at least 4 mm.
Who cannot join
- Patients with inappropriate implantation situates (patients with foremost bony deficiencies or sever bone resorption).
- Patient with severe clenching or bruxism.
- Heavy smokers or drug abusers.
- Psychiatric complications or impractical prospects.
- Patients with bad oral hygiene.
- Systemic conditions that may impact soft or hard tissue curing.
- Patients with history of radiation treatment in the head and neck area.
- Pregnant female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Different Customized Healing Abutment Materials on Peri-Implant Soft Tissue Profile
This study aimed to estimate the impact of various customized healing abutments materials on the peri-implant soft tissue profile
Read the detailed description
A dental implant is a method for the replacement of lost teeth, with an excellent prospering percentage plus lasting functional rehabilitation without requiring any preparation of the nearby teeth.
The usage of a healing abutment is one of the crucial clinical procedures that follows implant placement. It aids in establishing a stable and natural gingival emergence profile by supporting soft tissue shaping and shielding the implant platform. Various materials are available for healing abutments, which have an impact on biocompatibility, aesthetic results, soft tissue reaction, and patient comfort throughout the healing process.
Polyether ether ether ketone (PEEK) healing abutments are offering a non-metallic, lightweight option with a modulus of elasticity similar to bone, but they have lower surface hardness compared to titanium and zirconia, and long-term data is still developing.
3D printed hybrid resin materials were introduced earlier, allowing faster and precise fabrication of permanent dental restorations. P-Crown V4 material is a newly introduced 3D-printed nanoceramic-filled resin reported to contain up to 70% nanoceramic filler to enhance strength and hardness.
- Being tested
- Titanium healing abutment, Polyetheretherketone (PEEK), 3D-printed hybrid resin (P crownV4)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium healing abutmentProcedure or surgery
Patients received a standard ready-made titanium healing abutment (control group).
Polyetheretherketone (PEEK)Procedure or surgery
Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material.
3D-printed hybrid resin (P crownV4)Procedure or surgery
Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients received a standard ready-made titanium healing abutment (control group). Receives: Procedure: Titanium healing abutment |
| Group II | Experimental | Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material. Receives: Procedure: Polyetheretherketone (PEEK) |
| Group III | Experimental | Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material. Receives: Procedure: 3D-printed hybrid resin (P crownV4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Plaque Index
The Modified Plaque Index was used to assess the degree of Plaque Accumulation. 0 No plaque
- Plaque only detected with the probe
- Plaque visible with naked eye
- Abundant plaque
Measured: Two months after healing abutment placement
Secondary outcomes (2)
Modified gingival index
The modified gingival index was used to assess the gingival condition.
Each surface was evaluated and assigned a score from 0 to 4:
0 No bleeding
- Isolated bleeding
- Confluent bleeding
- Profuse bleeding
Measured: Two months after healing abutment placement
Papilla index (Jemt Index)
The papilla index (Jemt Index) was used to assess the Papilla condition. 0 No papilla present; no soft tissue curvature; empty space present.
- Less than half of the papilla height is present
- At least half of the papilla height is present, but it does not completely fill the space.
- The papilla fills the entire embrasure space and fills the gap completely (optimal).
- The papilla is hyperplastic covering too much of the tooth/implant.
Measured: Two months after healing abutment placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Dec 2025
- Primary completion4 Jul 2026
- Study completion4 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImplantStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angham Ibrahim Elgendy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697066
- Sponsor's protocol ID
- R-FP-11-25-3233
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Customized Healing Abutment Materials on Peri-Implant Soft Tissue Profile
- ClinicalTrials.gov ID
- NCT07697066
- Acronym / sponsor ID
- R-FP-11-25-3233
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 4 Jul 2026 (actual)
- Study completion
- 4 Jul 2026 (actual)
- First posted
- 10 Jul 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.
This study aimed to estimate the impact of various customized healing abutments materials on the peri-implant soft tissue profile
Detailed description
A dental implant is a method for the replacement of lost teeth, with an excellent prospering percentage plus lasting functional rehabilitation without requiring any preparation of the nearby teeth.
The usage of a healing abutment is one of the crucial clinical procedures that follows implant placement. It aids in establishing a stable and natural gingival emergence profile by supporting soft tissue shaping and shielding the implant platform. Various materials are available for healing abutments, which have an impact on biocompatibility, aesthetic results, soft tissue reaction, and patient comfort throughout the healing process.
Polyether ether ether ketone (PEEK) healing abutments are offering a non-metallic, lightweight option with a modulus of elasticity similar to bone, but they have lower surface hardness compared to titanium and zirconia, and long-term data is still developing.
3D printed hybrid resin materials were introduced earlier, allowing faster and precise fabrication of permanent dental restorations. P-Crown V4 material is a newly introduced 3D-printed nanoceramic-filled resin reported to contain up to 70% nanoceramic filler to enhance strength and hardness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: Titanium healing abutmentPatients received a standard ready-made titanium healing abutment (control group). |
| Group II | Experimental | Procedure: Polyetheretherketone (PEEK)Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material. |
| Group III | Experimental | Procedure: 3D-printed hybrid resin (P crownV4)Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patient's aged 25-45 years old
- Patients with missing tooth needing solitary implant placement rehabilitation in the maxillary anterior regions with neighboring and opposite normal teeth.
- Adequate mesial, distal, and interocclusal space for implant engagement and its absolute re-establishment.
- Patients can recite and mark the informed approval paper.
- Medically free patients or with controlled systemic disease.
Key exclusion criteria (8 listed)
- Patients with inappropriate implantation situates (patients with foremost bony deficiencies or sever bone resorption).
- Patient with severe clenching or bruxism.
- Heavy smokers or drug abusers.
- Psychiatric complications or impractical prospects.
- Patients with bad oral hygiene.
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 |
|---|---|---|
| Titanium healing abutmentPatients received a standard ready-made titanium healing abutment (control group). | Procedure or surgery | Group I |
| Polyetheretherketone (PEEK)Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material. | Procedure or surgery | Group II |
| 3D-printed hybrid resin (P crownV4)Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material. | Procedure or surgery | Group III |
Primary outcome
Modified Plaque Index
Time frame: Two months after healing abutment placement
The Modified Plaque Index was used to assess the degree of Plaque Accumulation. 0 No plaque 1. Plaque only detected with the probe 2. Plaque visible with naked eye 3. Abundant plaque
2 secondary outcomes
Modified gingival index
Time frame: Two months after healing abutment placement
Papilla index (Jemt Index)
Time frame: Two months after healing abutment placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Titanium healing abutment, Polyetheretherketone (PEEK) and 3D-printed hybrid resin (P crownV4) in people with Implant and Healing, run by Tanta University 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 9 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: finished, as of the sponsor's last update on 10 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Plaque Index (time frame: Two months after healing abutment placement). 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 10 Jul 2026.