Missing ToothNCT07095881
Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment
A study testing Zirconia-based composite customized healing abutment and Conventional composite customized healing abutment. in people with Missing Tooth, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if using zirconia-based composite customized healing abutment can have a favorable effect on peri implant soft tissue that may be related to the superior biological properties of zirconium nano particles regarding increased biocompatibility and decreased inflammatory… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Missing Tooth
- What is being tested?
- Zirconia-based composite customized healing abutment and Conventional composite customized healing abutment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jan 2025to Dec 2026
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire (Pendleton et al., 2004).
- Both genders.
- Age from 20-50 years.
- Missing tooth to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures (Beretta et al., 2019).
- Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor (Baltayan et al., 2016).
- Sound Mesial and distal neighboring teeth.
Show all 9Show fewer
- At least 6 natural teeth remaining in the same arch .
- Mouth opening ≥ 30mm.
- Thick phenotype.
Who cannot join
- Poor oral hygiene condition.
- Pregnant and lactating females.
- Smokers.
- Vulnerable groups (Prisoners and handicaps).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Ain Shams University
Cairo, Abaseya, 7154411
Dean of the faculty, +20222639083, administrator@asfd.asu.edu.eg
Ahmed A El Sayed, MSc Perio
About this study
Official title: Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment: A Randomized Controlled Clinical Study With Biochemical Analysis
The goal of this clinical trial is to learn if using zirconia-based composite customized healing abutment can have a favorable effect on peri implant soft tissue that may be related to the superior biological properties of zirconium nano particles regarding increased biocompatibility and decreased inflammatory response Patients that are eligible for implant placement
The main question it aims to answer is:
Read more
Does zirconia-based composite customized healing abutment have a significantly different effect on peri-implant soft tissue compared to conventional composite customized healing abutment in terms of biological properties or biocompatibility or inflammatory response? Researchers will compare between direct zirconia-based composite customized healing abutments vs conventional composite customized healing abutments placed simultaneously with delayed dental implant placement.
Participants will be undergo the following procedures :
- Presurgical procedures:
- Detailed clinical examination, full history, and radiographic examination (CBCT) will be performed initially to aid in patients' selection.
- After enrollment, all participants will sign the informed consent.
- All participants will be subjected to periodontal phase I treatment including periodontal supra- and sub-gingival debridement and oral hygiene instructions.
- Surgical procedures:
- After local anesthesia administration, flap is raised, osteotomy site preparation, and implant will be placed.
- Check the ISQ to exceed or equal 70 unit.
- A customized Light-cured Direct Zirconia-Based Composite or A customized Light-cured Direct Convential Composite Healing Abutment will be placed.
Then all participants should follow up at the following times : Baseline, 1,2 and 3 months after implantation.
Read the detailed description
Light-cured direct zirconia-based composite has many potential uses in dentistry, because of mechanical and biological reasons maintaining the health of peri-implant soft tissues during healing.
Direct zirconia-based composite customized healing abutments have superior properties such as biocompatibility, chemical stability, antibacterial and mechanical properties.
Aim of the study: This study will be carried out to compare zirconia-based composite customized healing abutments vs conventional composite customized healing abutment placed simultaneously with delayed dental implant placement.
Materials and Methods: This will be done by clinical evaluation of peri-implant soft tissue changes. Moreover, peri-implant sulcus fluid (PISF) will be measured for the level of Interleukin-1 beta (IL-1β) in the gingival crevicular fluid.
PICOTS Elements:
Patient/Problem:Patients that are eligible for implant placement within inclusion criteria.
Intervention: Zirconia-based composite customized healing abutment. Comparator: Conventional composite customized healing abutment.
Outcome:
Primary outcome : Clinical evaluation of peri-implant soft tissue changes via pink esthetic score and papilla index.
Secondary outcome : Biochemical assessment of IL-1β level in the gingival crevicular fluid using Periopaper strip .
Time: Baseline, 1,2 and 3 months after implantation. Biochemical assessment : after 2 months of implantation. Setting: Faculty of Dentistry, Ain Shams University. Clinical Relevance: The result will affect the gold standard in choosing the customized healing abutment material for implant patients, regarding which one offers better peri-implant soft tissue results, healing stimulation, and less inflammatory response.
- Conditions
- Missing Tooth
- Being tested
- Zirconia-based composite customized healing abutment, Conventional composite customized healing abutment.
- Keywords
- Implant, dental implant, Delayed implant, Healing abutment, Customized healing abutment, Zirconia-based composite customized healing abutment, Conventional composite customized healing abutment, Biochemical Analysis, Pink esthetic Score, Papilla index, PISF samples, IL-1β
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia-based composite customized healing abutmentOther
using Zirconia-based composite in customized healing abutment fabrication
Conventional composite customized healing abutment.Other
using conventional composite in customized healing abutment fabrication
| Study group | Role | What they receive |
|---|---|---|
| Zirconia-based composite customized healing abutment | Active comparator | Participants in this arm will receive a customized healing abutment made of Zirconia-based composite material fabricated chairside.
The abutment will be designed to mimic the emergence profile of the final prosthesis, aiming to optimize soft tissue shaping and healing.
The abutment is placed immediately after implant placement and will remain in place for 3 months. Receives: Other: Zirconia-based composite customized healing abutment |
| Conventional composite customized healing abutment | Active comparator | Participants in this arm will receive a customized healing abutment made of conventional composite material fabricated chairside.
The abutment will be designed to mimic the emergence profile of the final prosthesis, aiming to optimize soft tissue shaping and healing.
The abutment is placed immediately after implant placement and will remain in place for 3 months. Receives: Other: Conventional composite customized healing abutment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score
The Pink Esthetic Score is used to evaluate the soft tissue esthetics around single-tooth implants.
It includes 7 parameters: mesial and distal papilla, tissue contours, gingival level, alveolar process, and both the color and texture of the soft tissue. Each is scored from 0 to 2, with higher scores reflecting more natural esthetics. For the papillae, a score of 0 indicates the papilla is missing, 1 is incomplete, and 2 is complete. Tissue contours are rated as unnatural (0), virtually natural (1), or natural (2). Gingival level is assessed based on vertical discrepancy with adjacent teeth: more than 2 mm scores 0, 1-2 mm scores 1, and less than 1 mm scores 2. The alveolar process is scored as clearly resorbed (0), slightly resorbed (1), or showing no difference (2). Finally, both soft tissue color and texture are evaluated against the neighboring tissue: a clear difference (0), a slight difference (1),no difference (2). The maximum PES is 14, represents ideal soft tissue esthetics.
Measured: Baseline, 1,2 and 3 months after implantation.
Papilla index
The Papilla Index is a clinical tool used to evaluate the degree of interdental papilla fill in the proximal space around implants.
It is scored on a scale from 0 to 4. A score of 0 indicates that no papilla is present. A score of 1 means less than half of the papilla height is visible. A score of 2 is assigned when half or more of the papilla height is present, though not completely filling the space.
A score of 3 denotes a papilla that fully occupies the entire proximal space, representing the ideal scenario.
A score of 4 indicates a hyperplastic papilla, where the tissue extends beyond the normal contours.
Measured: baseline, 1,2 and 3 months
Secondary outcomes (1)
Biochemical assessment of IL-1β level in the gingival crevicular fluid
Biochemical assessment of IL-1β level in the gingival crevicular fluid using Periopaper strip.
Measured: After 2 months of implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start6 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Missing ToothStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- Randomized, controlled, parallel design, two arms clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed asem elsayed abd elmoteleb, Ain Shams University
- Investigators
- Hadeel G Salem, Lecturer, Study director, Faculty of Dentistry - Ain Shams UniversityNevine H Kheir El Din, Professor, Study director, Faculty of Dentistry - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095881
- Sponsor's protocol ID
- FDASU-REC 1437
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Pendleton N, Clague JE, Horan MA, Rabbitt PM, Jones M, Coward R, Lowe C, McInnes L. Concordance of Cornell medical index self-reports to structured clinical assessment for the identification of physical health status. Arch Gerontol Geriatr. 2004 May-Jun;38(3):261-9. doi: 10.1016/j.archger.2003.10.005.
PubMed 15066312Lashkarizadeh N, Foroudisefat M, Abyari S, Mohammadi M, Lashkarizadeh L. Is It Safe to Reuse Healing Abutments? An Experimental Study on IL-1beta and TNF-alpha Cytokine Levels in Peri-Implant Crevicular Fluid. J Prosthodont. 2022 Jun;31(5):399-404. doi: 10.1111/jopr.13474. Epub 2022 Feb 19.
PubMed 34962679Kunrath MF, Gupta S, Lorusso F, Scarano A, Noumbissi S. Oral Tissue Interactions and Cellular Response to Zirconia Implant-Prosthetic Components: A Critical Review. Materials (Basel). 2021 May 25;14(11):2825. doi: 10.3390/ma14112825.
PubMed 34070589Khatri M, Bansal M, Puri K, Mehrotra S, Kumar A, Rehan M. Evaluation of the correlation between interleukin 1beta levels in peri-implant crevicular fluid as an adjunctive diagnostic marker with clinical and radiographic parameters for assessing the peri-implant health status. Natl J Maxillofac Surg. 2022 Sep-Dec;13(3):421-429. doi: 10.4103/njms.njms_337_21. Epub 2022 Dec 10.
PubMed 36683945Chokaree P, Poovarodom P, Chaijareenont P, Yavirach A, Rungsiyakull P. Biomaterials and Clinical Applications of Customized Healing Abutment-A Narrative Review. J Funct Biomater. 2022 Dec 10;13(4):291. doi: 10.3390/jfb13040291.
PubMed 36547551Beretta 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 31546800Bannunah AM. Biomedical Applications of Zirconia-Based Nanomaterials: Challenges and Future Perspectives. Molecules. 2023 Jul 15;28(14):5428. doi: 10.3390/molecules28145428.
PubMed 37513299Baltayan 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 26917203Almadani, T. M., Amer, A.-F. M., Abdallah, H. M., & El Sayed, I. S. Clinical and radiographic evaluation of peri-implant tissue changes associated with use of standard versus customized healing abutments. Al-Azhar Journal of Dental Science (2023), 26(2), 229-239.
Ramenzoni LL, Fluckiger LB, Attin T, Schmidlin PR. Effect of Titanium and Zirconium Oxide Microparticles on Pro-Inflammatory Response in Human Macrophages under Induced Sterile Inflammation: An In Vitro Study. Materials (Basel). 2021 Jul 27;14(15):4166. doi: 10.3390/ma14154166.
PubMed 34361359
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment: A Randomized Controlled Clinical Study With Biochemical Analysis
- ClinicalTrials.gov ID
- NCT07095881
- Acronym / sponsor ID
- FDASU-REC 1437
- Conditions
- Missing Tooth
- Keywords
- Implant, dental implant, Delayed implant, Healing abutment, Customized healing abutment, Zirconia-based composite customized healing abutment, Conventional composite customized healing abutment, Biochemical Analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jul 2025 (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 goal of this clinical trial is to learn if using zirconia-based composite customized healing abutment can have a favorable effect on peri implant soft tissue that may be related to the superior biological properties of zirconium nano particles regarding increased biocompatibility and decreased inflammatory response Patients that are eligible for implant placement
The main question it aims to answer is:
Does zirconia-based composite customized healing abutment have a significantly different effect on peri-implant soft tissue compared to conventional composite customized healing abutment in terms of biological properties or biocompatibility or inflammatory response? Researchers will compare between direct zirconia-based composite customized healing abutments vs conventional composite customized healing abutments placed simultaneously with delayed dental implant placement.
Participants will be undergo the following procedures :
- Presurgical procedures:
- Detailed clinical examination, full history, and radiographic examination (CBCT) will be performed initially to aid in patients' selection.
- After enrollment, all participants will sign the informed consent.
- All participants will be subjected to periodontal phase I treatment including periodontal supra- and sub-gingival debridement and oral hygiene instructions.
- Surgical procedures:
- After local anesthesia administration, flap is raised, osteotomy site preparation, and implant will be placed.
- Check the ISQ to exceed or equal 70 unit.
- A customized Light-cured Direct Zirconia-Based Composite or A customized Light-cured Direct Convential Composite Healing Abutment will be placed.
Then all participants should follow up at the following times : Baseline, 1,2 and 3 months after implantation.
Detailed description
Light-cured direct zirconia-based composite has many potential uses in dentistry, because of mechanical and biological reasons maintaining the health of peri-implant soft tissues during healing.
Direct zirconia-based composite customized healing abutments have superior properties such as biocompatibility, chemical stability, antibacterial and mechanical properties.
Aim of the study: This study will be carried out to compare zirconia-based composite customized healing abutments vs conventional composite customized healing abutment placed simultaneously with delayed dental implant placement.
Materials and Methods: This will be done by clinical evaluation of peri-implant soft tissue changes. Moreover, peri-implant sulcus fluid (PISF) will be measured for the level of Interleukin-1 beta (IL-1β) in the gingival crevicular fluid.
PICOTS Elements:
Patient/Problem:Patients that are eligible for implant placement within inclusion criteria.
Intervention: Zirconia-based composite customized healing abutment. Comparator: Conventional composite customized healing abutment.
Outcome:
Primary outcome : Clinical evaluation of peri-implant soft tissue changes via pink esthetic score and papilla index.
Secondary outcome : Biochemical assessment of IL-1β level in the gingival crevicular fluid using Periopaper strip .
Time: Baseline, 1,2 and 3 months after implantation. Biochemical assessment : after 2 months of implantation. Setting: Faculty of Dentistry, Ain Shams University. Clinical Relevance: The result will affect the gold standard in choosing the customized healing abutment material for implant patients, regarding which one offers better peri-implant soft tissue results, healing stimulation, and less inflammatory response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, parallel design, two arms clinical trial
| Arm | Type | Receives |
|---|---|---|
| Zirconia-based composite customized healing abutment | Active comparator | Other: Zirconia-based composite customized healing abutmentParticipants in this arm will receive a customized healing abutment made of Zirconia-based composite material fabricated chairside. The abutment will be designed to mimic the emergence profile of the final prosthesis, aiming to optimize soft tissue shaping and healing. The abutment is placed immediately after implant placement and will remain in place for 3 months. |
| Conventional composite customized healing abutment | Active comparator | Other: Conventional composite customized healing abutment.Participants in this arm will receive a customized healing abutment made of conventional composite material fabricated chairside. The abutment will be designed to mimic the emergence profile of the final prosthesis, aiming to optimize soft tissue shaping and healing. The abutment is placed immediately after implant placement and will remain in place for 3 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire (Pendleton et al., 2004).
- Both genders.
- Age from 20-50 years.
- Missing tooth to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures (Beretta et al., 2019).
- Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor (Baltayan et al., 2016).
Key exclusion criteria (4 listed)
- Poor oral hygiene condition.
- Pregnant and lactating females.
- Smokers.
- Vulnerable groups (Prisoners and handicaps).
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 |
|---|---|---|
| Zirconia-based composite customized healing abutmentusing Zirconia-based composite in customized healing abutment fabrication | Other | Zirconia-based composite customized healing abutment |
| Conventional composite customized healing abutment.using conventional composite in customized healing abutment fabrication | Other | Conventional composite customized healing abutment |
Primary outcome
Pink Esthetic Score
Time frame: Baseline, 1,2 and 3 months after implantation.
The Pink Esthetic Score is used to evaluate the soft tissue esthetics around single-tooth implants. It includes 7 parameters: mesial and distal papilla, tissue contours, gingival level, alveolar process, and both the color and texture of the soft tissue. Each is scored from 0 to 2, with higher scores reflecting more natural esthetics. For the papillae, a score of 0 indicates the papilla is missing, 1 is incomplete, and 2 is complete. Tissue contours are rated as unnatural (0), virtually natural (1), or natural (2). Gingival level is assessed based on vertical discrepancy with adjacent teeth: more than 2 mm scores 0, 1-2 mm scores 1, and less than 1 mm scores 2. The alveolar process is scored as clearly resorbed (0), slightly resorbed (1), or showing no difference (2). Finally, both soft tissue color and texture are evaluated against the neighboring tissue: a clear difference (0), a slight difference (1),no difference (2). The maximum PES is 14, represents ideal soft tissue esthetics.
Papilla index
Time frame: baseline, 1,2 and 3 months
The Papilla Index is a clinical tool used to evaluate the degree of interdental papilla fill in the proximal space around implants. It is scored on a scale from 0 to 4. A score of 0 indicates that no papilla is present. A score of 1 means less than half of the papilla height is visible. A score of 2 is assigned when half or more of the papilla height is present, though not completely filling the space. A score of 3 denotes a papilla that fully occupies the entire proximal space, representing the ideal scenario. A score of 4 indicates a hyperplastic papilla, where the tissue extends beyond the normal contours.
1 secondary outcome
Biochemical assessment of IL-1β level in the gingival crevicular fluid
Time frame: After 2 months of implant placement
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 31 Jul 2025.
- Background: PubMed 15066312Pendleton N, Clague JE, Horan MA, Rabbitt PM, Jones M, Coward R, Lowe C, McInnes L. Concordance of Cornell medical index self-reports to structured clinical assessment for the identification of physical health status. Arch Gerontol Geriatr. 2004 May-Jun;38(3):261-9. doi: 10.1016/j.archger.2003.10.005.
- Background: PubMed 34962679Lashkarizadeh N, Foroudisefat M, Abyari S, Mohammadi M, Lashkarizadeh L. Is It Safe to Reuse Healing Abutments? An Experimental Study on IL-1beta and TNF-alpha Cytokine Levels in Peri-Implant Crevicular Fluid. J Prosthodont. 2022 Jun;31(5):399-404. doi: 10.1111/jopr.13474. Epub 2022 Feb 19.
- Background: PubMed 34070589Kunrath MF, Gupta S, Lorusso F, Scarano A, Noumbissi S. Oral Tissue Interactions and Cellular Response to Zirconia Implant-Prosthetic Components: A Critical Review. Materials (Basel). 2021 May 25;14(11):2825. doi: 10.3390/ma14112825.
- Background: PubMed 36683945Khatri M, Bansal M, Puri K, Mehrotra S, Kumar A, Rehan M. Evaluation of the correlation between interleukin 1beta levels in peri-implant crevicular fluid as an adjunctive diagnostic marker with clinical and radiographic parameters for assessing the peri-implant health status. Natl J Maxillofac Surg. 2022 Sep-Dec;13(3):421-429. doi: 10.4103/njms.njms_337_21. Epub 2022 Dec 10.
- Background: PubMed 36547551Chokaree P, Poovarodom P, Chaijareenont P, Yavirach A, Rungsiyakull P. Biomaterials and Clinical Applications of Customized Healing Abutment-A Narrative Review. J Funct Biomater. 2022 Dec 10;13(4):291. doi: 10.3390/jfb13040291.
- 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 37513299Bannunah AM. Biomedical Applications of Zirconia-Based Nanomaterials: Challenges and Future Perspectives. Molecules. 2023 Jul 15;28(14):5428. doi: 10.3390/molecules28145428.
- 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.
- BackgroundAlmadani, T. M., Amer, A.-F. M., Abdallah, H. M., & El Sayed, I. S. Clinical and radiographic evaluation of peri-implant tissue changes associated with use of standard versus customized healing abutments. Al-Azhar Journal of Dental Science (2023), 26(2), 229-239.
- Background: PubMed 34361359Ramenzoni LL, Fluckiger LB, Attin T, Schmidlin PR. Effect of Titanium and Zirconium Oxide Microparticles on Pro-Inflammatory Response in Human Macrophages under Induced Sterile Inflammation: An In Vitro Study. Materials (Basel). 2021 Jul 27;14(15):4166. doi: 10.3390/ma14154166.
- Individual participant dataSharing planned: Yes
Related trials for Missing Tooth
Not yet recruitingPhase 4
S-TiUltra Implant Study
Missing Tooth/Teeth
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
Recruiting
Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide
Vertical Bone Defects, Missing Tooth/Teeth
RecruitingObservational study
Post Market Clinical Follow up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry
Missing Teeth
Not yet recruiting
Multicenter Clinical Study on the Efficacy and Esthetic Outcomes of Immediate Implant Placement Using the Socket-Shield Technique Versus Conventional Immediate Implantation in the Anterior Maxillary Esthetic Zone
Teeth Absent, Teeth Missing
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.
Hadeel G Salem, Lecturer study director
Faculty of Dentistry - Ain Shams University
Nevine H Kheir El Din, Professor study director
Faculty of Dentistry - 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 Zirconia-based composite customized healing abutment and Conventional composite customized healing abutment. in people with Missing Tooth, 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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. 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?
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?
Contact Ahmed A El Sayed, MSc Perio (+201127999187, ahmed.abdelmoteleb.std@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink Esthetic Score (time frame: Baseline, 1,2 and 3 months after implantation.). The study lists 2 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 NCT07095881, which also lists 10 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 31 Jul 2025.