Peri-ImplantitisNCT07906899
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
A study testing implant placement with a customized healing abutment and implant placement with a prefabricated (stock) healing abutment. in people with Peri-Implantitis, run by Cairo University.
Trial summary
The aim of this study is to compare customized and stock healing abutments for peri-implant soft tissue changes after immediate implant placement in the maxillary esthetic zone, and to assess the feasibility of a full-scale trial. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- implant placement with a customized healing abutment and implant placement with a prefabricated (stock) healing abutment.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to May 2027
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Good general health (ASA I or II).
- Adult patients above 18 years of age.
- Males or females.
- Good oral hygiene and compliance with follow-up visits.
- Willing to sign the informed consent.
- Non-restorable (hopeless) tooth in the maxillary esthetic zone (canine to canine).
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- Intact facial bone wall of the socket after extraction.
- Sufficient bone apical and palatal to the socket to achieve primary implant stability (≥ 35 Ncm).
- Presence of adjacent and opposing natural teeth.
- Healthy periodontium around adjacent teeth.
Who cannot join
- Participants with uncontrolled systemic illness.
- Pregnant or lactating females.
- Smokers.
- Concomitant participation in another study.
- Heavy bruxism habits.
- History of radiotherapy to the head and neck region or bisphosphonate therapy.
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- Patients who refuse to participate.
- Acute infection or abscess at the site.
- Facial bone wall dehiscence or defect.
- Insufficient bone for primary stability.
- Active periodontal disease.
- Previous bone augmentation or implant at the same site.
About this study
Official title: Esthetic Outcomes and Digital Soft Tissue Assessment of Customized Versus Stock Healing Abutments for Immediate Implants in the Maxillary Esthetic Zone: A Pilot Randomized Controlled Trial
The aim of this study is to compare customized and stock healing abutments for peri-implant soft tissue changes after immediate implant placement in the maxillary esthetic zone, and to assess the feasibility of a full-scale trial.
Read the detailed description
Preservation of the peri-implant soft tissue contour and papillae after immediate implant placement is essential for a predictable esthetic result. If customized healing abutments provide better soft tissue outcomes than stock abutments, they could be recommended as a routine step in immediate implant placement in the esthetic zone. Because high-quality comparative evidence is lacking, the present pilot randomized trial was designed to compare the peri-implant soft tissue changes (Pink Esthetic Score at 6 months) around customized versus stock healing abutments, and to provide the feasibility data (recruitment, retention, variability of outcomes) needed to calculate the sample size of a full-scale trial.
- Conditions
- Peri-Implantitis
- Being tested
- implant placement with a customized healing abutment, implant placement with a prefabricated (stock) healing abutment.
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placement with a customized healing abutmentProcedure or surgery
Immediate implant placement with a customized healing abutment
implant placement with a prefabricated (stock) healing abutment.Procedure or surgery
Immediate implant placement with a prefabricated (stock) healing abutment.
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant placement with a customized healing abutment | Experimental | A customized healing abutment replicating the emergence profile of the extracted tooth will be fabricated chairside using resin composite on a titanium abutment / digitally designed and milled and connected to the implant at the same surgical visit. Its design will be based on the cervical cross-section of the extracted tooth. Receives: Procedure: implant placement with a customized healing abutment |
| Immediate implant placement with a prefabricated (stock) healing abutment. | Active comparator | • A prefabricated healing abutment will be selected and connected to the implant at the same surgical visit, with the screw torqued according to the manufacturer's instructions. Receives: Procedure: implant placement with a prefabricated (stock) healing abutment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score (PES)
PES criteria scoring (0-14)
Measured: 6 months
Secondary outcomes (7)
Extended Pink Esthetic Score (E-PES)
E-PES criteria Scoring (0-18)
Measured: 6 months
Probing depth (PD)
by peridontal probe in millimeters
Measured: 6 months
Buccal soft tissue contour
Intraoral scan / stone cast superimposition in millimeters
Measured: 6 months
Keratinized mucosa width (KMW)
Periodontal probe
Measured: 6 months
Marginal bone level (MBL)
CBCT / periapical radiograph
Measured: 6 months
Digital Assesment of Buccal Mucosa
digital scanner
Measured: 6 months
Patient Satisfaction for Esthetics
binary questionnaire (yes/No)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El-Said Mohamed Ghazy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906899
- Sponsor's protocol ID
- 10-2026
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Outcomes and Digital Soft Tissue Assessment of Customized Versus Stock Healing Abutments for Immediate Implants in the Maxillary Esthetic Zone: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07906899
- Acronym / sponsor ID
- 10-2026
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Oct 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.
The aim of this study is to compare customized and stock healing abutments for peri-implant soft tissue changes after immediate implant placement in the maxillary esthetic zone, and to assess the feasibility of a full-scale trial.
Detailed description
Preservation of the peri-implant soft tissue contour and papillae after immediate implant placement is essential for a predictable esthetic result. If customized healing abutments provide better soft tissue outcomes than stock abutments, they could be recommended as a routine step in immediate implant placement in the esthetic zone. Because high-quality comparative evidence is lacking, the present pilot randomized trial was designed to compare the peri-implant soft tissue changes (Pink Esthetic Score at 6 months) around customized versus stock healing abutments, and to provide the feasibility data (recruitment, retention, variability of outcomes) needed to calculate the sample size of a full-scale trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implant placement with a customized healing abutment | Experimental | Procedure: implant placement with a customized healing abutmentA customized healing abutment replicating the emergence profile of the extracted tooth will be fabricated chairside using resin composite on a titanium abutment / digitally designed and milled and connected to the implant at the same surgical visit. Its design will be based on the cervical cross-section of the extracted tooth. |
| Immediate implant placement with a prefabricated (stock) healing abutment. | Active comparator | Procedure: implant placement with a prefabricated (stock) healing abutment.• A prefabricated healing abutment will be selected and connected to the implant at the same surgical visit, with the screw torqued according to the manufacturer's instructions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Good general health (ASA I or II).
- Adult patients above 18 years of age.
- Males or females.
- Good oral hygiene and compliance with follow-up visits.
- Willing to sign the informed consent.
Key exclusion criteria (12 listed)
- Participants with uncontrolled systemic illness.
- Pregnant or lactating females.
- Smokers.
- Concomitant participation in another study.
- Heavy bruxism 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 |
|---|---|---|
| implant placement with a customized healing abutmentImmediate implant placement with a customized healing abutment | Procedure or surgery | Immediate implant placement with a customized healing abutment |
| implant placement with a prefabricated (stock) healing abutment.Immediate implant placement with a prefabricated (stock) healing abutment. | Procedure or surgery | Immediate implant placement with a prefabricated (stock) healing abutment. |
Primary outcome
Pink Esthetic Score (PES)
Time frame: 6 months
PES criteria scoring (0-14)
7 secondary outcomes
Extended Pink Esthetic Score (E-PES)
Time frame: 6 months
Probing depth (PD)
Time frame: 6 months
Buccal soft tissue contour
Time frame: 6 months
Keratinized mucosa width (KMW)
Time frame: 6 months
Marginal bone level (MBL)
Time frame: 6 months
Digital Assesment of Buccal Mucosa
Time frame: 6 months
Patient Satisfaction for Esthetics
Time frame: 6 months
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 Nov 2026.
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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 implant placement with a customized healing abutment and implant placement with a prefabricated (stock) healing abutment. in people with Peri-Implantitis, 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 10 inclusion and 12 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 Nov 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?
Pink Esthetic Score (PES) (time frame: 6 months). 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 Nov 2026.