Peri-implant MucositisNCT06645444
Immediate Implant Placement With Different Materials of Customized Healing Abutment for Guiding Peri-implant Soft Tissue Healing in Posterior Teeth
A study testing immediate implant placement with customized PEEK healing abutment in people with Peri-implant Mucositis, run by Cairo University at 1 site in Egypt.
Trial summary
: Immediate Implant Placement with different materials of customized healing abutment for guiding Peri-implant Soft Tissue Healing in Posterior Teeth: A Randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- immediate implant placement with customized PEEK healing abutment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 May 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Periodontally and systemic healthy patients
- Patients aged > 18 years
- Non- restored teeth for many reasons (i.e. endodontic failure, unworthy for treatment in deep caries/non-caries lesion and root fracture), locate in the posterior area in the maxillary or mandibular arch indicate for customized implant with no need for additional bone and soft tissue augmentation procedures.
- An adequate vertical bone for immediate implant placement.
- Implants will be positioned with adequate primary stability so that transmucosal healing can be accomplished.
- No taken medications known to interfere healing or periodontal tissue health or bone metabolism.
- No previous periodontal surgery at involved sites.
- Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
Who cannot join
- Patients with active periodontal diseases (bleeding on probing- probing depth > 4 mm) or those under orthodontic treatment.
- Poor oral hygiene (full mouth plaque score > 25% and full mouth bleeding score > 25%)
- Smoking habits (> 10 cigarettes/day)
- Severe acute or chronic periodontitis
- Severe bruxism habits
- History of oral/IV bisphosphonates taking
Show all 12Show fewer
- Remote or recent radiation therapy in the oro-maxillo-facial area or recent chemotherapy.
- Xerostomia
- Pregnant and lactating mothers
- Patients who have been received periodontal surgery in the study area during the last year.
- Clinical or radiographic signs of periapical pathology contraindicating immediate implant placement.
- Implants showing signs of peri-implant mucositis and peri-implantitis during the study period will be excluded from the following analyses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Implant Placement With Different Materials of Customized Healing Abutment for Guiding Peri-implant Soft Tissue Healing in Posterior Teeth: A Randomized Controlled Clinical Trial
: Immediate Implant Placement with different materials of customized healing abutment for guiding Peri-implant Soft Tissue Healing in Posterior Teeth: A Randomized controlled clinical trial.
Read the detailed description
This randomized clinical trial evaluates the effect of customized PEEK healing abutment versus composite healing abutment regarding Clinical evaluate
- Gingival margin height
- Gingival contour width
- Gingival volume in BL \& MD aspects on guiding the peri- implant soft tissue emergency profile in posterior teeth after immediate implant placement
- Conditions
- Peri-implant Mucositis
- Being tested
- immediate implant placement with customized PEEK healing abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placement with customized PEEK healing abutmentOther
- an intraoral examination will be done and a digital impression will be taken by the intraoral scanner (MEDIT i500) for a pre-extraction digital model, and CBCT will be taken for prosthetic-driven planning.
- Once the treatment plan formulated, both STL (Standard Triangle Language) and DICOM (CBCT raw data) files format will be sent to produce the digital surgical guide with metal sleeve.
- Then, a customized PEEK healing abutment will be made mimicking the anatomical cervical contour and pseudo-CEJ will be made by merging the STL and DICOM digitally and the exterior surface of the healing abutment will be designed to resemble a tooth.
- Then, the technicians will mill the customized healing abutment digital design from a pre-milled 14 × 14 mm PEEK block (BioHPP, Bredent®, Bolzano, Italy) with a non-hex connection type, polished it, and sterilized it.
- The digital surgical guide with a metal sleeve will be back for scheduled patient implant surgery.
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement with customized composite healing abutment | Active comparator | * extraction of the Posterior teeth will be done with minimally invasive technique using periotome.
* Then, the digital surgical guide will be placed, and will be checked the affinity of the reference window with other teeth accurately in the optimal position. The osteotomies will be prepared with a surgical-guided surgery kit through a digital surgical guide and drill direction will be ensured by radiographic taking. Implant fixture insertion will be performed through this digital surgical guide.
* All patients will receive a bone-level implant with varying diameter and length in each case. After implant placement, the operator will scan the surrounding gingiva with a scan body immediately for a post-extraction digital model.
* Then the spaces between the implant fixture and alveolar bone wall will be filled with locally harvested autogenous bone and xenograft grafting material (OsteoBiol Gen-Os, Sweden). Receives: Other: immediate implant placement with customized PEEK healing abutment |
| immediate implant placement with customized PEEK healing abutment | Experimental | * an intraoral examination will be done and a digital impression will be taken by the intraoral scanner (MEDIT i500) for a pre-extraction digital model, and CBCT will be taken for prosthetic-driven planning.
* Once the treatment plan formulated, both STL (Standard Triangle Language) and DICOM (CBCT raw data) files format will be sent to produce the digital surgical guide with metal sleeve.
* Then, a customized PEEK healing abutment will be made mimicking the anatomical cervical contour and pseudo-CEJ will be made by merging the STL and DICOM digitally and the exterior surface of the healing abutment will be designed to resemble a tooth.
* Then, the technicians will mill the customized healing abutment digital design from a pre-milled 14 × 14 mm PEEK block (BioHPP, Bredent®, Bolzano, Italy) with a non-hex connection type, polished it, and sterilized it.
* The digital surgical guide with a metal sleeve will be back for scheduled patient implant surgery. Receives: Other: immediate implant placement with customized PEEK healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival margin height
Gingival margin height will be measured from the highest gingival margin point in the buccal, lingual, mesial, and distal sides perpendicular to the platform plane (buccal height; BH, palatal/lingual height; LH, mesial height; MH and distal height; DH).
Measured: Day 0 - month 12
Gingival contour width
The contour width will be measured from the outer sur face on the buccal and lingual sides to the implant center on the platform plane (buccal width; BW and palatal/lingual width; LW).
Measured: Day 0 - month 12
Gingival volume in BL & MD aspects
Gingival volume will be measured on the gingiva above the platform plane for total gingival volume and separated with a mid-mesiodistal plane through the implant center for buccal and lingual gingival volume (total buccolingual volume; BLV, buccal volume; BV and lingual volume; LV).
Measured: Day 0 - month 12
Secondary outcomes (1)
The Functional Implant Prosthodontics Score
The Functional Implant Prosthodontics Score will be measured through five variables in order to limit bias: (1) interproximal contact and papillae, (2) occlusion static and dynamic, (3) design color and contour, (4) mucosa quality and quantity, and (5) bone x-ray. A scoring scheme of 0-1-2 resulting in a maximum score of ten (5X2) per implant reconstruction.
Measured: Day 0 - month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jun 2025
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Helal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645444
- Sponsor's protocol ID
- 591024
- Status last verified
- May 2026
- First submitted
- 9 Oct 2024
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement With Different Materials of Customized Healing Abutment for Guiding Peri-implant Soft Tissue Healing in Posterior Teeth: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06645444
- Acronym / sponsor ID
- 591024
- Conditions
- Peri-implant Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 16 Oct 2024 (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.
: Immediate Implant Placement with different materials of customized healing abutment for guiding Peri-implant Soft Tissue Healing in Posterior Teeth: A Randomized controlled clinical trial.
Detailed description
This randomized clinical trial evaluates the effect of customized PEEK healing abutment versus composite healing abutment regarding Clinical evaluate
- Gingival margin height
- Gingival contour width
- Gingival volume in BL \& MD aspects on guiding the peri- implant soft tissue emergency profile in posterior teeth after immediate implant placement
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 customized composite healing abutment | Active comparator | Other: immediate implant placement with customized PEEK healing abutment* extraction of the Posterior teeth will be done with minimally invasive technique using periotome. * Then, the digital surgical guide will be placed, and will be checked the affinity of the reference window with other teeth accurately in the optimal position. The osteotomies will be prepared with a surgical-guided surgery kit through a digital surgical guide and drill direction will be ensured by radiographic taking. Implant fixture insertion will be performed through this digital surgical guide. * All patients will receive a bone-level implant with varying diameter and length in each case. After implant placement, the operator will scan the surrounding gingiva with a scan body immediately for a post-extraction digital model. * Then the spaces between the implant fixture and alveolar bone wall will be filled with locally harvested autogenous bone and xenograft grafting material (OsteoBiol Gen-Os, Sweden). |
| immediate implant placement with customized PEEK healing abutment | Experimental | Other: immediate implant placement with customized PEEK healing abutment* an intraoral examination will be done and a digital impression will be taken by the intraoral scanner (MEDIT i500) for a pre-extraction digital model, and CBCT will be taken for prosthetic-driven planning. * Once the treatment plan formulated, both STL (Standard Triangle Language) and DICOM (CBCT raw data) files format will be sent to produce the digital surgical guide with metal sleeve. * Then, a customized PEEK healing abutment will be made mimicking the anatomical cervical contour and pseudo-CEJ will be made by merging the STL and DICOM digitally and the exterior surface of the healing abutment will be designed to resemble a tooth. * Then, the technicians will mill the customized healing abutment digital design from a pre-milled 14 × 14 mm PEEK block (BioHPP, Bredent®, Bolzano, Italy) with a non-hex connection type, polished it, and sterilized it. * The digital surgical guide with a metal sleeve will be back for scheduled patient implant surgery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
Key exclusion criteria (12 listed)
- Patients with active periodontal diseases (bleeding on probing- probing depth > 4 mm) or those under orthodontic treatment.
- Poor oral hygiene (full mouth plaque score > 25% and full mouth bleeding score > 25%)
- Smoking habits (> 10 cigarettes/day)
- Severe acute or chronic periodontitis
- Severe 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 |
|---|---|---|
| immediate implant placement with customized PEEK healing abutment* an intraoral examination will be done and a digital impression will be taken by the intraoral scanner (MEDIT i500) for a pre-extraction digital model, and CBCT will be taken for prosthetic-driven planning. * Once the treatment plan formulated, both STL (Standard Triangle Language) and DICOM (CBCT raw data) files format will be sent to produce the digital surgical guide with metal sleeve. * Then, a customized PEEK healing abutment will be made mimicking the anatomical cervical contour and pseudo-CEJ will be made by merging the STL and DICOM digitally and the exterior surface of the healing abutment will be designed to resemble a tooth. * Then, the technicians will mill the customized healing abutment digital design from a pre-milled 14 × 14 mm PEEK block (BioHPP, Bredent®, Bolzano, Italy) with a non-hex connection type, polished it, and sterilized it. * The digital surgical guide with a metal sleeve will be back for scheduled patient implant surgery. | Other | immediate implant placement with customized PEEK healing abutment, immediate implant placement with customized composite healing abutment |
Primary outcome
Gingival margin height
Time frame: Day 0 - month 12
Gingival margin height will be measured from the highest gingival margin point in the buccal, lingual, mesial, and distal sides perpendicular to the platform plane (buccal height; BH, palatal/lingual height; LH, mesial height; MH and distal height; DH).
Gingival contour width
Time frame: Day 0 - month 12
The contour width will be measured from the outer sur face on the buccal and lingual sides to the implant center on the platform plane (buccal width; BW and palatal/lingual width; LW).
Gingival volume in BL & MD aspects
Time frame: Day 0 - month 12
Gingival volume will be measured on the gingiva above the platform plane for total gingival volume and separated with a mid-mesiodistal plane through the implant center for buccal and lingual gingival volume (total buccolingual volume; BLV, buccal volume; BV and lingual volume; LV).
1 secondary outcome
The Functional Implant Prosthodontics Score
Time frame: Day 0 - month 12
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 28 May 2026.
- Individual participant dataSharing planned: Yes
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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 immediate implant placement with customized PEEK healing abutment in people with Peri-implant Mucositis, run by Cairo 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 8 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: finished, as of the sponsor's last update on 28 May 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?
Gingival margin height (time frame: Day 0 - month 12). The study lists 3 primary outcomes in all. 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 28 May 2026.