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Not yet recruitingNCT07906899Updated Nov 4, 2026

Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue

An interventional study of implant placement with a customized healing abutment and implant placement with a prefabricated (stock) healing abutment. in Peri-Implantitis, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Peri-Implantitis

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03

In context

Peri-Implantitis

315 studies on the registry are indexed under Peri-Implantitis; 87 are open to participants now.

This study's planned enrollment of 28 is below the median of 40 across 192 interventional studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,929 studies on the registry; 1,450 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Good general health (ASA I or II).
  2. Adult patients above 18 years of age.
  3. Males or females.
  4. Good oral hygiene and compliance with follow-up visits.
  5. Willing to sign the informed consent.
  6. Non-restorable (hopeless) tooth in the maxillary esthetic zone (canine to canine).
  7. Intact facial bone wall of the socket after extraction.
  8. Sufficient bone apical and palatal to the socket to achieve primary implant stability (≥ 35 Ncm).
  9. Presence of adjacent and opposing natural teeth.
  10. Healthy periodontium around adjacent teeth.

Exclusion criteria

Exclusion Criteria:

  1. Participants with uncontrolled systemic illness.
  2. Pregnant or lactating females.
  3. Smokers.
  4. Concomitant participation in another study.
  5. Heavy bruxism habits.
  6. History of radiotherapy to the head and neck region or bisphosphonate therapy.
  7. Patients who refuse to participate.
  8. Acute infection or abscess at the site.
  9. Facial bone wall dehiscence or defect.
  10. Insufficient bone for primary stability.
  11. Active periodontal disease.
  12. Previous bone augmentation or implant at the same site.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Immediate implant placement with a customized healing abutment

    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.

    Procedure: implant placement with a customized healing abutment

  • Active comparator
    Immediate 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.

    Procedure: implant placement with a prefabricated (stock) healing abutment.

Interventions

  • Procedureimplant placement with a customized healing abutment

    Immediate implant placement with a customized healing abutment

  • Procedureimplant placement with a prefabricated (stock) healing abutment.

    Immediate implant placement with a prefabricated (stock) healing abutment.

06

What researchers measure

Primary outcomes

  1. Pink Esthetic Score (PES)

    PES criteria scoring (0-14)

    Time frame: 6 months

Secondary outcomes

  1. Extended Pink Esthetic Score (E-PES)

    E-PES criteria Scoring (0-18)

    Time frame: 6 months

  2. Probing depth (PD)

    by peridontal probe in millimeters

    Time frame: 6 months

  3. Buccal soft tissue contour

    Intraoral scan / stone cast superimposition in millimeters

    Time frame: 6 months

  4. Keratinized mucosa width (KMW)

    Periodontal probe

    Time frame: 6 months

  5. Marginal bone level (MBL)

    CBCT / periapical radiograph

    Time frame: 6 months

  6. Digital Assesment of Buccal Mucosa

    digital scanner

    Time frame: 6 months

  7. Patient Satisfaction for Esthetics

    binary questionnaire (yes/No)

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.

Of 117 non-industry interventional studies with no phase under Peri-Implantitis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 6 months is below that.

Counting every sponsor, half of 124 studies reached it within 26 months; a quarter within 12 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Oct 30, 2026
StartEst.
Nov 2026
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
2 added, 1 removed
What changed in the outcomes
  • AddedDigital Assesment of Buccal MucosaTime frame: 6 months
  • AddedPatient Satisfaction for EstheticsTime frame: 6 months
  • RemovedPeri-implant mucosal levelTime frame: 6 months
Nov 4, 2026
Registered
First appeared on the registry
Oct 30, 2026
Show all 2 updates
  1. Nov 4, 2026
    Secondary outcomes 2 added, 1 removed
    What changed in the outcomes
    • AddedDigital Assesment of Buccal MucosaTime frame: 6 months
    • AddedPatient Satisfaction for EstheticsTime frame: 6 months
    • RemovedPeri-implant mucosal levelTime frame: 6 months
    + 1 other change: identifiers
  2. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07906899
Lead sponsor
Cairo University
Responsible party
Ahmed El-Said Mohamed Ghazy (Master's degree Student, Cairo University) — Principal investigator
First posted
Oct 30, 2026
Start date
Nov 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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