Dental ImplantsNCT05989061
PEEK Versus Titanium Customized Healing Abutments
A study testing PEEK customized healing abutment and Titanium customized healing abutment in people with Dental Implants, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study suggests that if the investigators used customized healing abutments synthesized from PEEK may have a favorable effect on peri-implant soft tissues regarding decreased plaque accumulation and healing stimulation compared to the customized conventional titanium healing abutments. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- PEEK customized healing abutment and Titanium customized healing abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to Oct 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire .
- Both genders.
- Age from 20-50 years.
- Missing tooth in esthetic zone (Anterior/Premolar) to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures.
- Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor
- BuccoLingual bone width ≥ 6 mm.
Show all 12Show fewer
- Mesio distal space ≥ 7 mm
- Sound Mesial and distal neighboring teeth.
- At least 6 natural teeth remaining in the same arch .
- Mouth opening ≥ 30mm.
- Enough keratinized mucosa.
- Thick phenotype.
Who cannot join
- Poor oral hygiene condition.
- Pregnant and lactating females.
- Smokers.
Trial locations and contacts
1 site in 1 country.
Hadeel G. Al Malahy, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Ain Shams University
Cairo
About this study
Official title: PEEK Versus Titanium Customized Healing Abutments: Evaluation of Peri-implant Soft Tissues and Sulcus Fluid Bacterial Load
The study suggests that if the investigators used customized healing abutments synthesized from PEEK may have a favorable effect on peri-implant soft tissues regarding decreased plaque accumulation and healing stimulation compared to the customized conventional titanium healing abutments.
Read the detailed description
Successful aesthetic implant therapy has several sequential goals such as prosthetically driven 3D implant placement. Implant placement must be done in the ideal position to support the restoration and the surrounding soft and hard tissues. The placement of a definitive restoration should also be in harmony with the adjacent natural teeth and surrounding soft tissue.
Guided implant surgery can provide precise, predictable, and safe implant placement. Computer-generated surgical guides vary in design according to the dental condition (edentulous or partially edentulous), type of support (tooth, mucosa, or bone), and the degree of limitation (non-limiting, partially-limiting, or completely limiting).
The use of healing abutments has the function which enables adequate healing of peri-implant soft tissue and promoting a good profile of peri-implant mucosa that allows an adequate emergence profile of the prostheses supported by the implant. They are available in different lengths and project through the soft tissue into the oral cavity.
Janakievski stated that prefabricated healing abutments are unable to support the supracrestal soft tissues because of their circular profile. Therefore, a custom healing abutment is preferred because it provides a replica of the definitive restoration of the patient's gingival architecture.
An evaluation of the use of customized healing abutments has been performed aiming to assess possible advantages associated with this treatment modality. This procedure allows to maintain the peri-implant tissue and improve aesthetics until crown delivery. CAD/CAM enables the fabrication of high-quality implant abutments from solid blocks of different materials.
The contours of the healing abutment are based on the contours of a provisionally designed definitive prosthesis. The healing abutment promotes tissue healing and obtains contours that are well-matched with the contours of the definitive prosthesis.
Currently healing abutments made of polymers such as polyetheretherketone (PEEK) which have been used in orthopedic surgery, are used in dentistry, because of aesthetic \& biological reasons maintaining the health of peri-implant soft tissues during healing.
Polyetheretherketone (PEEK) healing abutments can be chosen instead of titanium healing abutments because of their superior properties such as biocompatibility, inert chemical properties, white color, and decreased liability for biofilm accumulation.
Research Question "May PEEK healing abutment have a favorable effect on peri-implant soft tissue that may be related to the superior biological properties of PEEK regarding both decreased biofilm accumulation\& healing stimulation?"
- Conditions
- Dental Implants
- Being tested
- PEEK customized healing abutment, Titanium customized healing abutment
- Keywords
- Customized Healing Abutment, PEEK, Peri-implant soft tissue, Dental implants, Titanium, Esthetic Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK customized healing abutmentDevice
Guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery
Titanium customized healing abutmentDevice
Guided delayed implant and a customized Titanium healing abutment placed simultaneously with implant surgery
| Study group | Role | What they receive |
|---|---|---|
| PEEK customized healing abutment. | Experimental | Group I (Customized PEEK Healing Abutment):
13 patients will receive guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery Receives: Device: PEEK customized healing abutment |
| Titanium customized healing abutment. | Active comparator | Group II (Customized Titanium Healing Abutment):
13 patients will receive guided delayed implant and a customized titanium healing abutment placed simultaneously with implant surgery. Receives: Device: Titanium customized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of peri-implant soft tissue changes
Clinical evaluation of peri-implant soft tissue changes the Probing Depth (PD).
Measured: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Clinical evaluation of peri-implant soft tissue changes
Clinical evaluation of peri-implant soft tissue changes the Plaque Index (PI) score.
Measured: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Clinical evaluation of peri-implant soft tissue changes
Clinical evaluation of peri-implant soft tissue changes the Gingival Index (GI)score.
Measured: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Clinical evaluation of peri-implant soft tissue changes
Clinical evaluation of peri-implant soft tissue changes the Gingival Bleeding Time Index (GBTI).
Measured: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Clinical evaluation of peri-implant soft tissue changes
Clinical evaluation of peri-implant soft tissue changes the Width of keratinized tissue (WKT).
Measured: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Secondary outcomes (1)
Biochemical evaluation
Biochemical evaluation of peri-implant sulcus fluid (PISF) total bacterial load.
Measured: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar El Desouki, Ain Shams University
- Investigators
- Ahmed E. Amr, Assoc Prof, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989061
- Sponsor's protocol ID
- FDASU-RecIM122219
- Status last verified
- Jun 2024
- First submitted
- 21 Jul 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baltayan S, Pi-Anfruns J, Aghaloo T, Moy PK. The Predictive Value of Resonance Frequency Analysis Measurements in the Surgical Placement and Loading of Endosseous Implants. J Oral Maxillofac Surg. 2016 Jun;74(6):1145-52. doi: 10.1016/j.joms.2016.01.048. Epub 2016 Feb 1.
PubMed 26917203Beretta M, Poli PP, Pieriboni S, Tansella S, Manfredini M, Cicciu M, Maiorana C. Peri-Implant Soft Tissue Conditioning by Means of Customized Healing Abutment: A Randomized Controlled Clinical Trial. Materials (Basel). 2019 Sep 19;12(18):3041. doi: 10.3390/ma12183041.
PubMed 31546800Cakan U, Delilbasi C, Er S, Kivanc M. Is it safe to reuse dental implant healing abutments sterilized and serviced by dealers of dental implant manufacturers? An in vitro sterility analysis. Implant Dent. 2015 Apr;24(2):174-9. doi: 10.1097/ID.0000000000000198.
PubMed 25706262Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.
PubMed 19885446Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.
PubMed 24660198Chew M, Tompkins G, Tawse-Smith A, Waddell JN, Ma S. Reusing Titanium Healing Abutments: Comparison of Two Decontamination Methods. Int J Prosthodont. 2018 November/December;31(6):613-618. doi: 10.11607/ijp.5881. Epub 2018 Jul 30.
PubMed 30339159Cochran DL, Nummikoski PV, Schoolfield JD, Jones AA, Oates TW. A prospective multicenter 5-year radiographic evaluation of crestal bone levels over time in 596 dental implants placed in 192 patients. J Periodontol. 2009 May;80(5):725-33. doi: 10.1902/jop.2009.080401.
PubMed 19405825de Almeida EO, Pellizzer EP, Goiatto MC, Margonar R, Rocha EP, Freitas AC Jr, Anchieta RB. Computer-guided surgery in implantology: review of basic concepts. J Craniofac Surg. 2010 Nov;21(6):1917-21. doi: 10.1097/SCS.0b013e3181f4b1a0.
PubMed 21119455Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Finelle G, Lee SJ. Guided Immediate Implant Placement with Wound Closure by Computer-Aided Design/Computer-Assisted Manufacture Sealing Socket Abutment: Case Report. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):e63-e67. doi: 10.11607/jomi.4770.
PubMed 28291855Jemt T. Measurements of tooth movements in relation to single-implant restorations during 16 years: a case report. Clin Implant Dent Relat Res. 2005;7(4):200-8. doi: 10.1111/j.1708-8208.2005.tb00065.x.
PubMed 16336911Joda T, Ferrari M, Braegger U. A digital approach for one-step formation of the supra-implant emergence profile with an individualized CAD/CAM healing abutment. J Prosthodont Res. 2016 Jul;60(3):220-3. doi: 10.1016/j.jpor.2016.01.005. Epub 2016 Feb 9.
PubMed 26868927Lang LA, Sierraalta M, Hoffensperger M, Wang RF. Evaluation of the precision of fit between the Procera custom abutment and various implant systems. Int J Oral Maxillofac Implants. 2003 Sep-Oct;18(5):652-8.
PubMed 14579952Margonar R, Queiroz TP, Luvizuto ER, Betoni-Junior W, Zocal EA. Mandibular rehabilitation using immediate implant loading after computer-guided surgery. J Craniofac Surg. 2012 Mar;23(2):e129-32. doi: 10.1097/SCS.0b013e31824cdb74.
PubMed 22446446Mehra M, Somohano T, Choi M. Mandibular fibular graft reconstruction with CAD/CAM technology: A clinical report and literature review. J Prosthet Dent. 2016 Jan;115(1):123-8. doi: 10.1016/j.prosdent.2015.05.012. Epub 2015 Sep 11.
PubMed 26372630
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEEK Versus Titanium Customized Healing Abutments: Evaluation of Peri-implant Soft Tissues and Sulcus Fluid Bacterial Load
- ClinicalTrials.gov ID
- NCT05989061
- Acronym / sponsor ID
- FDASU-RecIM122219
- Conditions
- Dental Implants
- Keywords
- Customized Healing Abutment, PEEK, Peri-implant soft tissue, Dental implants, Titanium, Esthetic Zone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 14 Aug 2023 (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 study suggests that if the investigators used customized healing abutments synthesized from PEEK may have a favorable effect on peri-implant soft tissues regarding decreased plaque accumulation and healing stimulation compared to the customized conventional titanium healing abutments.
Detailed description
Successful aesthetic implant therapy has several sequential goals such as prosthetically driven 3D implant placement. Implant placement must be done in the ideal position to support the restoration and the surrounding soft and hard tissues. The placement of a definitive restoration should also be in harmony with the adjacent natural teeth and surrounding soft tissue.
Guided implant surgery can provide precise, predictable, and safe implant placement. Computer-generated surgical guides vary in design according to the dental condition (edentulous or partially edentulous), type of support (tooth, mucosa, or bone), and the degree of limitation (non-limiting, partially-limiting, or completely limiting).
The use of healing abutments has the function which enables adequate healing of peri-implant soft tissue and promoting a good profile of peri-implant mucosa that allows an adequate emergence profile of the prostheses supported by the implant. They are available in different lengths and project through the soft tissue into the oral cavity.
Janakievski stated that prefabricated healing abutments are unable to support the supracrestal soft tissues because of their circular profile. Therefore, a custom healing abutment is preferred because it provides a replica of the definitive restoration of the patient's gingival architecture.
An evaluation of the use of customized healing abutments has been performed aiming to assess possible advantages associated with this treatment modality. This procedure allows to maintain the peri-implant tissue and improve aesthetics until crown delivery. CAD/CAM enables the fabrication of high-quality implant abutments from solid blocks of different materials.
The contours of the healing abutment are based on the contours of a provisionally designed definitive prosthesis. The healing abutment promotes tissue healing and obtains contours that are well-matched with the contours of the definitive prosthesis.
Currently healing abutments made of polymers such as polyetheretherketone (PEEK) which have been used in orthopedic surgery, are used in dentistry, because of aesthetic \& biological reasons maintaining the health of peri-implant soft tissues during healing.
Polyetheretherketone (PEEK) healing abutments can be chosen instead of titanium healing abutments because of their superior properties such as biocompatibility, inert chemical properties, white color, and decreased liability for biofilm accumulation.
Research Question "May PEEK healing abutment have a favorable effect on peri-implant soft tissue that may be related to the superior biological properties of PEEK regarding both decreased biofilm accumulation\& healing stimulation?"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK customized healing abutment. | Experimental | Device: PEEK customized healing abutmentGroup I (Customized PEEK Healing Abutment): 13 patients will receive guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery |
| Titanium customized healing abutment. | Active comparator | Device: Titanium customized healing abutmentGroup II (Customized Titanium Healing Abutment): 13 patients will receive guided delayed implant and a customized titanium healing abutment placed simultaneously with implant surgery. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire .
- Both genders.
- Age from 20-50 years.
- Missing tooth in esthetic zone (Anterior/Premolar) to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures.
- Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor
Key exclusion criteria (3 listed)
- Poor oral hygiene condition.
- Pregnant and lactating females.
- Smokers.
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 |
|---|---|---|
| PEEK customized healing abutmentGuided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery | Device | PEEK customized healing abutment. |
| Titanium customized healing abutmentGuided delayed implant and a customized Titanium healing abutment placed simultaneously with implant surgery | Device | Titanium customized healing abutment. |
Primary outcome
Clinical evaluation of peri-implant soft tissue changes
Time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Clinical evaluation of peri-implant soft tissue changes the Probing Depth (PD).
Clinical evaluation of peri-implant soft tissue changes
Time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Clinical evaluation of peri-implant soft tissue changes the Plaque Index (PI) score.
Clinical evaluation of peri-implant soft tissue changes
Time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Clinical evaluation of peri-implant soft tissue changes the Gingival Index (GI)score.
Clinical evaluation of peri-implant soft tissue changes
Time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Clinical evaluation of peri-implant soft tissue changes the Gingival Bleeding Time Index (GBTI).
Clinical evaluation of peri-implant soft tissue changes
Time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Clinical evaluation of peri-implant soft tissue changes the Width of keratinized tissue (WKT).
1 secondary outcome
Biochemical evaluation
Time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 26917203Baltayan S, Pi-Anfruns J, Aghaloo T, Moy PK. The Predictive Value of Resonance Frequency Analysis Measurements in the Surgical Placement and Loading of Endosseous Implants. J Oral Maxillofac Surg. 2016 Jun;74(6):1145-52. doi: 10.1016/j.joms.2016.01.048. Epub 2016 Feb 1.
- Background: PubMed 31546800Beretta M, Poli PP, Pieriboni S, Tansella S, Manfredini M, Cicciu M, Maiorana C. Peri-Implant Soft Tissue Conditioning by Means of Customized Healing Abutment: A Randomized Controlled Clinical Trial. Materials (Basel). 2019 Sep 19;12(18):3041. doi: 10.3390/ma12183041.
- Background: PubMed 25706262Cakan U, Delilbasi C, Er S, Kivanc M. Is it safe to reuse dental implant healing abutments sterilized and serviced by dealers of dental implant manufacturers? An in vitro sterility analysis. Implant Dent. 2015 Apr;24(2):174-9. doi: 10.1097/ID.0000000000000198.
- Background: PubMed 19885446Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.
- Background: PubMed 24660198Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.
- Background: PubMed 30339159Chew M, Tompkins G, Tawse-Smith A, Waddell JN, Ma S. Reusing Titanium Healing Abutments: Comparison of Two Decontamination Methods. Int J Prosthodont. 2018 November/December;31(6):613-618. doi: 10.11607/ijp.5881. Epub 2018 Jul 30.
- Background: PubMed 19405825Cochran DL, Nummikoski PV, Schoolfield JD, Jones AA, Oates TW. A prospective multicenter 5-year radiographic evaluation of crestal bone levels over time in 596 dental implants placed in 192 patients. J Periodontol. 2009 May;80(5):725-33. doi: 10.1902/jop.2009.080401.
- Background: PubMed 21119455de Almeida EO, Pellizzer EP, Goiatto MC, Margonar R, Rocha EP, Freitas AC Jr, Anchieta RB. Computer-guided surgery in implantology: review of basic concepts. J Craniofac Surg. 2010 Nov;21(6):1917-21. doi: 10.1097/SCS.0b013e3181f4b1a0.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 28291855Finelle G, Lee SJ. Guided Immediate Implant Placement with Wound Closure by Computer-Aided Design/Computer-Assisted Manufacture Sealing Socket Abutment: Case Report. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):e63-e67. doi: 10.11607/jomi.4770.
- Background: PubMed 16336911Jemt T. Measurements of tooth movements in relation to single-implant restorations during 16 years: a case report. Clin Implant Dent Relat Res. 2005;7(4):200-8. doi: 10.1111/j.1708-8208.2005.tb00065.x.
- Background: PubMed 26868927Joda T, Ferrari M, Braegger U. A digital approach for one-step formation of the supra-implant emergence profile with an individualized CAD/CAM healing abutment. J Prosthodont Res. 2016 Jul;60(3):220-3. doi: 10.1016/j.jpor.2016.01.005. Epub 2016 Feb 9.
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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.
Hadeel G. Al Malahy, Lecturer contact
Ahmed E. Amr, Assoc Prof study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEK customized healing abutment and Titanium customized healing abutment in people with Dental Implants, run by Ain Shams 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 12 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar F. El Desouki, Master student (+201010876119, SamarFakhrEldin@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of peri-implant soft tissue changes (time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05989061, which also lists 25 linked publications.
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 Jun 2024; AzTrials last refreshed its copy on 28 Oct 2026.