Dental Esthetic, Dental Care for Children, Dental CrownsNCT07618871
Prefabricated CAD/CAM PEEK Crowns For Primary Molars Restoration
A study testing Prefabricated CAD/CAM PEEK with 0.2 mm thickness, Prefabricated CAD/CAM PEEK with 0.4 mm thickness and CAD/CAM-fabricated PEEK Crowns in people with Dental Esthetic, Dental Care for Children, Dental Crowns, run by Arab International University at 1 site in Syria.
Trial summary
This Split-mouth randomized clinical trial aims to evaluate CAD/CAM prefabricated Polyether ether ketone crowns for primary molars restoration after pulpotomy compared to Stainless steel crowns Over follow-up periods of 3, 6, and 12 months, the sample included 60 children aged 5-9 years who had bilateral mandibular… Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Dental Esthetic, Dental Care for Children, Dental Crowns
- What is being tested?
- Prefabricated CAD/CAM PEEK with 0.2 mm thickness, Prefabricated CAD/CAM PEEK with 0.4 mm thickness and CAD/CAM-fabricated PEEK Crowns
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSyria
- Study dates
- 2 Apr 2024to 26 Aug 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children aged 5-9 years.
- Children requiring pulpotomy of mandibular second primary molars.
- Cooperative children rated as positive or definitely positive on the Frankl behavior scale.
- No acute or chronic abscess at the anesthesia site.
Who cannot join
- Root resorption exceeding the apical third.
- Non-restorable teeth.
- Presence of swelling, fistula, or acute or chronic pulpitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Minimally Prepared CAD/CAM Polyetheretherketone (PEEK) Crowns Efficacy in Restoring Primary Molars
This Split-mouth randomized clinical trial aims to evaluate CAD/CAM prefabricated Polyether ether ketone crowns for primary molars restoration after pulpotomy compared to Stainless steel crowns Over follow-up periods of 3, 6, and 12 months, the sample included 60 children aged 5-9 years who had bilateral mandibular second primary molars.
Each child received a pulpotomy treatment followed by the placement of a stainless steel crown on one side and a PEEK crown on the contralateral side, distributed randomly.
Clinical parameters were subsequently evaluated during the three follow-up periods, including the gingival index, plaque index, bleeding on probing index, restoration retention and integrity, marginal adaptation, color stability, and both parental and child satisfaction.
Read the detailed description
Interest in the esthetic aspect of pediatric dental treatment has increased among both children and parents, as children's self-perception is strongly influenced by the appearance of their teeth from an early age. Most esthetic restorative options require extensive tooth preparation compared with stainless steel crowns (SSCs). However, only limited studies have investigated conservative esthetic alternatives for primary molars.
This randomized controlled clinical trial aimed to evaluate the clinical effectiveness of CAD-CAM prefabricated esthetic PEEK crowns compared with stainless steel crowns (SSCs) in restoring primary mandibular second molars after pulpotomy. Clinical performance was assessed according to restoration retention and integrity, gingival health, plaque accumulation, bleeding on probing, marginal adaptation, color stability, and child/parent satisfaction over follow-up periods of 3, 6, and 12 months.
The sample was randomly allocated using the website: randomization.com
A total crowns were randomly distributed into four groups (n=20 per group):
(A): Prefabricated CAD/CAM PEEK crowns with 0.2 mm thickness (B): Prefabricated CAD/CAM PEEK crowns with 0.4 mm thickness (C): CAD/CAM fabricated PEEK crowns prepared according to NuSmile recommendations (D): Stainless steel crowns (SSC). The study included healthy, cooperative children aged 5-9 years requiring pulpotomy treatment for mandibular second primary.
Clinical Procedure
Clinical and radiographic examinations are performed to confirm the indication for pulpotomy treatment, followed by completion of the study form. Local anesthesia and rubber dam isolation are carried out, and pulpotomy is performed according to the conventional technique described by Dean (2016). The tooth is then restored with glass ionomer cement.
After cement setting, conservative tooth preparation is performed using diamond burs with 1-2 mm occlusal reduction. For Groups I, II, and IV, proximal reduction is completed with minimal preparation. In Group III, tooth preparation follows NuSmile recommendations, including occlusal reduction, proximal opening, crown reduction, and a 1 mm subgingival finish line.
For Groups I, II, and IV, the appropriate crown size is selected, checked for marginal adaptation and proximal contacts, then cemented using Fuji I glass ionomer cement. Excess cement is removed using a dental explorer and dental floss.
For the CAD/CAM fabricated PEEK group, a silicone impression is taken and scanned digitally. Crowns are designed using Exocad software and fabricated with CAD-CAM technology. After polishing and internal surface conditioning with aluminum oxide particles, the crown is tried in, cemented with Fuji I glass ionomer cement, and excess cement is removed.
Clinical parameters are evaluated immediately after crown cementation for directly measurable baseline variables and during the three follow-up periods (after 3, 6, 12 months), including the gingival index, plaque index, bleeding on probing index, restoration retention and integrity, marginal adaptation, color stability, and both parental and child satisfaction.
- Being tested
- Prefabricated CAD/CAM PEEK with 0.2 mm thickness, Prefabricated CAD/CAM PEEK with 0.4 mm thickness, CAD/CAM-fabricated PEEK Crowns, Satinless steel crowns
- Keywords
- Polyetheretherketone, Prefabricated crowns, CAD/CAM, Stainless steel crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated CAD/CAM PEEK with 0.2 mm thicknessProcedure or surgery
The pulpotomized molar assigned to experimental group will be received A Polyether ether ketone prefabricated crown with 0.2mm thickness on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
Prefabricated CAD/CAM PEEK with 0.4 mm thicknessProcedure or surgery
The pulpotomized molar assigned to experimental group will be received A Polyether ether ketone prefabricated crown with 0.4mm thickness on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
CAD/CAM-fabricated PEEK CrownsProcedure or surgery
The pulpotomized molar assigned to experimental group will be received A CAD/CAM fabricated Polyether ether ketone crown on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
Satinless steel crownsProcedure or surgery
The pulpotomized molar assigned to control group will be received a Stainless steel crown as control group on one side of mandibular arch, and the other side will be received one of the arm 1, 2, or 3
| Study group | Role | What they receive |
|---|---|---|
| Prefabricated PEEK crowns of 0.2 mm thickness | Experimental | Minimally prepared teeth restored with prefabricated PEEK crowns of 0.2 mm wall thickness. Receives: Procedure: Prefabricated CAD/CAM PEEK with 0.2 mm thickness |
| Prefabricated PEEK crowns of 0.4 mm wall thickness | Experimental | Minimally prepared teeth restored with prefabricated PEEK crowns of 0.4 mm wall thickness. Receives: Procedure: Prefabricated CAD/CAM PEEK with 0.4 mm thickness |
| CAD/CAM-fabricated PEEK crowns | Experimental | Teeth receiving comprehensive preparation and restored with CAD/CAM-fabricated PEEK crowns following the NuSmile preparation protocol. Receives: Procedure: CAD/CAM-fabricated PEEK Crowns |
| Stainless steel crowns | Active comparator | Minimally prepared teeth restored with prefabricated stainless steel crowns, as the positive control group. Receives: Procedure: Satinless steel crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index
0 = No gingival inflammation.
- = Mild inflammation with slight changes in color and texture affecting part of the marginal gingiva or papilla.
- = Mild inflammation with changes in color and texture involving the entire marginal gingiva or papilla.
- = Moderate gingival inflammation with obvious redness, surface glazing, edema, and/or enlargement of the marginal gingiva or papilla.
- = Severe gingival inflammation with marked redness, edema and/or enlargement of the marginal gingiva or papilla, spontaneous bleeding, and ulceration.
Measured: Baseline, 3 months, 6 months, and 12 months postoperatively
Plaque Index
0 = No plaque accumulation around the gingival margin.
- = Slight plaque accumulation detected only by passing a probe.
- = Moderate plaque accumulation visible to the naked eye.
- = Heavy plaque accumulation on the crown surface, gingiva, and interdental areas.
Measured: Baseline, 3 months, 6 months, and 12 months postoperatively
Bleeding on Probing
Bleeding on probing is assessed using a Williams periodontal probe inserted into the gingival sulcus around each crowned tooth. Four sites (mesial, distal, buccal, and lingual) are examined, and bleeding is evaluated 10 seconds after probing as follows:
(-) No bleeding. (+) Bleeding present.
Measured: Baseline, 3 months, 6 months, and 12 months postoperatively
Wong-Baker Faces Scale
A Wong-Baker Faces Scale consisting of six expressive faces is used, ranging from "no hurts" to "hurts worst," to facilitate the child's selection of the appropriate face. The scale ranges from 0 to 10.
The child is given a questionnaire displaying the faces immediately after crown placement and is asked to choose the face that best represents their feeling at that moment. The child indicates the selected face by pointing to it, and the response is recorded in the study form.
Measured: Baseline, 3 months, 6 months, 12 months postoperatively
Secondary outcomes (4)
Color Stability
Color stability is assessed using a shade guide as a reference standard. The crown color is compared with the shade guide at each follow-up visit (3, 6, and 12 months) according to the following criteria:
0 = No color change.
- = Slight change from the original color.
- = Unacceptable color change.
Measured: 3 months, 6 months, 12 months postoperatively
Restoration retention and integrity
The clinical condition of the crown is evaluated during follow-up visits according to the following criteria:
0 = No visible fracture.
- = Minor crown fracture that is repairable.
- = Major crown fracture that can still be repaired.
- = Crown loss and exclusion from the study sample.
Measured: 3 months, 6 months, 12 months postoperatively
Marginal Adaptation
Marginal adaptation discrepancies were evaluated clinically using a sharp explorer and direct visual examination under dental operating light According to the modified United States Public Health Service (USPHS) criteria; (A): An Alpha grade represented a clinically ideal restoration with excellent marginal adaptation, no detectable gap on exploratory examination.
(B): A Bravo grade indicated a clinically acceptable restoration with a slight marginal discrepancy detectable by an explorer, but without dentin exposure.
(C): A Charlie grade was assigned to restorations that were clinically unacceptable due to a definite marginal gap, with exposed dentin.
(D): A Delta grade denotes the worst clinical condition, characterized by gross marginal failure, loss of retention, or other major defects, for which complete replacement of the restoration is required.
Measured: 3 months, 6 months, 12 months postoperatively
Patient/Parent Satisfaction
The child and one parent are asked about their satisfaction with the crowns regarding esthetics and function, and the responses are recorded in the patient form. Evaluation is performed as follows:
- = Completely satisfied with both esthetic and functional outcomes.
- = Satisfied with esthetic and functional outcomes with a minor remark.
- = Minor criticism without negative clinical effects or esthetic defects.
- = Desire for improvement in esthetic and functional aspects.
- = Completely dissatisfied.
Measured: 3 months, 6 months, 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start2 Apr 2024
- Primary completion10 Dec 2025
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental Esthetic, Dental Care for Children, Dental CrownsStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab International University
- Sponsor type
- University, hospital or other
- Collaborators
- Damascus University
- Responsible party
- Sponsor
- Investigators
- Bushra Munzer Shamma, MSc, DDS., Principal investigator, Damascus UniversityMohannad Laflouf, PhD, MSc, DDS., Study chair, Damascus UniversitySaleh Al Kurdi, PhD, MSc, DDS., Study director, Arab International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618871
- Sponsor's protocol ID
- 106/SRC/Sep.23.2024
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Attia MA, Blunt L, Bills P, Tawfik A, Radawn M. Micro-CT analysis of marginal and internal fit of milled and pressed polyetheretherketone single crowns. J Prosthet Dent. 2023 Jun;129(6):906.e1-906.e10. doi: 10.1016/j.prosdent.2023.03.018. Epub 2023 Apr 16.
PubMed 37072286Heimer S, Schmidlin PR, Roos M, Stawarczyk B. Surface properties of polyetheretherketone after different laboratory and chairside polishing protocols. J Prosthet Dent. 2017 Mar;117(3):419-425. doi: 10.1016/j.prosdent.2016.06.016. Epub 2016 Sep 28.
PubMed 27692577Chen Y, Liu W, Wu Z, Wang S, Li Y, Su B, Li S. Advantages and feasibility of prefabricated PEEK crowns for aesthetic restoration in primary teeth. Sci Rep. 2024 Nov 18;14(1):28398. doi: 10.1038/s41598-024-79306-1.
PubMed 39551812Stawarczyk B, Beuer F, Wimmer T, Jahn D, Sener B, Roos M, Schmidlin PR. Polyetheretherketone-a suitable material for fixed dental prostheses? J Biomed Mater Res B Appl Biomater. 2013 Oct;101(7):1209-16. doi: 10.1002/jbm.b.32932. Epub 2013 Apr 6.
PubMed 23564476Skirbutis G, Dzingute A, Masiliunaite V, Sulcaite G, Zilinskas J. PEEK polymer's properties and its use in prosthodontics. A review. Stomatologija. 2018;20(2):54-58.
PubMed 30531169Nagarathna, C., Deepthi, L., & Cam, C. A. D. (2026). Next Generation Smile Solutions - PEEK Crowns in Pediatric Dentistry. Journal of Chemical Health Risks, 16(1), 1734-1742.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Minimally Prepared CAD/CAM Polyetheretherketone (PEEK) Crowns Efficacy in Restoring Primary Molars
- ClinicalTrials.gov ID
- NCT07618871
- Acronym / sponsor ID
- 106/SRC/Sep.23.2024
- Keywords
- Polyetheretherketone, Prefabricated crowns, CAD/CAM, Stainless steel crowns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Arab International UniversityUniversity, hospital or other
- Collaborators
- Damascus University
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 1 Jun 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.
This Split-mouth randomized clinical trial aims to evaluate CAD/CAM prefabricated Polyether ether ketone crowns for primary molars restoration after pulpotomy compared to Stainless steel crowns Over follow-up periods of 3, 6, and 12 months, the sample included 60 children aged 5-9 years who had bilateral mandibular second primary molars.
Each child received a pulpotomy treatment followed by the placement of a stainless steel crown on one side and a PEEK crown on the contralateral side, distributed randomly.
Clinical parameters were subsequently evaluated during the three follow-up periods, including the gingival index, plaque index, bleeding on probing index, restoration retention and integrity, marginal adaptation, color stability, and both parental and child satisfaction.
Detailed description
Interest in the esthetic aspect of pediatric dental treatment has increased among both children and parents, as children's self-perception is strongly influenced by the appearance of their teeth from an early age. Most esthetic restorative options require extensive tooth preparation compared with stainless steel crowns (SSCs). However, only limited studies have investigated conservative esthetic alternatives for primary molars.
This randomized controlled clinical trial aimed to evaluate the clinical effectiveness of CAD-CAM prefabricated esthetic PEEK crowns compared with stainless steel crowns (SSCs) in restoring primary mandibular second molars after pulpotomy. Clinical performance was assessed according to restoration retention and integrity, gingival health, plaque accumulation, bleeding on probing, marginal adaptation, color stability, and child/parent satisfaction over follow-up periods of 3, 6, and 12 months.
The sample was randomly allocated using the website: randomization.com
A total crowns were randomly distributed into four groups (n=20 per group):
(A): Prefabricated CAD/CAM PEEK crowns with 0.2 mm thickness (B): Prefabricated CAD/CAM PEEK crowns with 0.4 mm thickness (C): CAD/CAM fabricated PEEK crowns prepared according to NuSmile recommendations (D): Stainless steel crowns (SSC). The study included healthy, cooperative children aged 5-9 years requiring pulpotomy treatment for mandibular second primary.
Clinical Procedure
Clinical and radiographic examinations are performed to confirm the indication for pulpotomy treatment, followed by completion of the study form. Local anesthesia and rubber dam isolation are carried out, and pulpotomy is performed according to the conventional technique described by Dean (2016). The tooth is then restored with glass ionomer cement.
After cement setting, conservative tooth preparation is performed using diamond burs with 1-2 mm occlusal reduction. For Groups I, II, and IV, proximal reduction is completed with minimal preparation. In Group III, tooth preparation follows NuSmile recommendations, including occlusal reduction, proximal opening, crown reduction, and a 1 mm subgingival finish line.
For Groups I, II, and IV, the appropriate crown size is selected, checked for marginal adaptation and proximal contacts, then cemented using Fuji I glass ionomer cement. Excess cement is removed using a dental explorer and dental floss.
For the CAD/CAM fabricated PEEK group, a silicone impression is taken and scanned digitally. Crowns are designed using Exocad software and fabricated with CAD-CAM technology. After polishing and internal surface conditioning with aluminum oxide particles, the crown is tried in, cemented with Fuji I glass ionomer cement, and excess cement is removed.
Clinical parameters are evaluated immediately after crown cementation for directly measurable baseline variables and during the three follow-up periods (after 3, 6, 12 months), including the gingival index, plaque index, bleeding on probing index, restoration retention and integrity, marginal adaptation, color stability, and both parental and child satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prefabricated PEEK crowns of 0.2 mm thickness | Experimental | Procedure: Prefabricated CAD/CAM PEEK with 0.2 mm thicknessMinimally prepared teeth restored with prefabricated PEEK crowns of 0.2 mm wall thickness. |
| Prefabricated PEEK crowns of 0.4 mm wall thickness | Experimental | Procedure: Prefabricated CAD/CAM PEEK with 0.4 mm thicknessMinimally prepared teeth restored with prefabricated PEEK crowns of 0.4 mm wall thickness. |
| CAD/CAM-fabricated PEEK crowns | Experimental | Procedure: CAD/CAM-fabricated PEEK CrownsTeeth receiving comprehensive preparation and restored with CAD/CAM-fabricated PEEK crowns following the NuSmile preparation protocol. |
| Stainless steel crowns | Active comparator | Procedure: Satinless steel crownsMinimally prepared teeth restored with prefabricated stainless steel crowns, as the positive control group. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children aged 5-9 years.
- Children requiring pulpotomy of mandibular second primary molars.
- Cooperative children rated as positive or definitely positive on the Frankl behavior scale.
- No acute or chronic abscess at the anesthesia site.
Key exclusion criteria (3 listed)
- Root resorption exceeding the apical third.
- Non-restorable teeth.
- Presence of swelling, fistula, or acute or chronic pulpitis.
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 |
|---|---|---|
| Prefabricated CAD/CAM PEEK with 0.2 mm thicknessThe pulpotomized molar assigned to experimental group will be received A Polyether ether ketone prefabricated crown with 0.2mm thickness on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group. | Procedure or surgery | Prefabricated PEEK crowns of 0.2 mm thickness |
| Prefabricated CAD/CAM PEEK with 0.4 mm thicknessThe pulpotomized molar assigned to experimental group will be received A Polyether ether ketone prefabricated crown with 0.4mm thickness on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group. | Procedure or surgery | Prefabricated PEEK crowns of 0.4 mm wall thickness |
| CAD/CAM-fabricated PEEK CrownsThe pulpotomized molar assigned to experimental group will be received A CAD/CAM fabricated Polyether ether ketone crown on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group. | Procedure or surgery | CAD/CAM-fabricated PEEK crowns |
| Satinless steel crownsThe pulpotomized molar assigned to control group will be received a Stainless steel crown as control group on one side of mandibular arch, and the other side will be received one of the arm 1, 2, or 3 | Procedure or surgery | Stainless steel crowns |
Primary outcome
Gingival Index
Time frame: Baseline, 3 months, 6 months, and 12 months postoperatively
0 = No gingival inflammation. 1. = Mild inflammation with slight changes in color and texture affecting part of the marginal gingiva or papilla. 2. = Mild inflammation with changes in color and texture involving the entire marginal gingiva or papilla. 3. = Moderate gingival inflammation with obvious redness, surface glazing, edema, and/or enlargement of the marginal gingiva or papilla. 4. = Severe gingival inflammation with marked redness, edema and/or enlargement of the marginal gingiva or papilla, spontaneous bleeding, and ulceration.
Plaque Index
Time frame: Baseline, 3 months, 6 months, and 12 months postoperatively
0 = No plaque accumulation around the gingival margin. 1. = Slight plaque accumulation detected only by passing a probe. 2. = Moderate plaque accumulation visible to the naked eye. 3. = Heavy plaque accumulation on the crown surface, gingiva, and interdental areas.
Bleeding on Probing
Time frame: Baseline, 3 months, 6 months, and 12 months postoperatively
Bleeding on probing is assessed using a Williams periodontal probe inserted into the gingival sulcus around each crowned tooth. Four sites (mesial, distal, buccal, and lingual) are examined, and bleeding is evaluated 10 seconds after probing as follows: (-) No bleeding. (+) Bleeding present.
Wong-Baker Faces Scale
Time frame: Baseline, 3 months, 6 months, 12 months postoperatively
A Wong-Baker Faces Scale consisting of six expressive faces is used, ranging from "no hurts" to "hurts worst," to facilitate the child's selection of the appropriate face. The scale ranges from 0 to 10. The child is given a questionnaire displaying the faces immediately after crown placement and is asked to choose the face that best represents their feeling at that moment. The child indicates the selected face by pointing to it, and the response is recorded in the study form.
4 secondary outcomes
Color Stability
Time frame: 3 months, 6 months, 12 months postoperatively
Restoration retention and integrity
Time frame: 3 months, 6 months, 12 months postoperatively
Marginal Adaptation
Time frame: 3 months, 6 months, 12 months postoperatively
Patient/Parent Satisfaction
Time frame: 3 months, 6 months, 12 months postoperatively
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 Oct 2026.
- Background: PubMed 37072286Attia MA, Blunt L, Bills P, Tawfik A, Radawn M. Micro-CT analysis of marginal and internal fit of milled and pressed polyetheretherketone single crowns. J Prosthet Dent. 2023 Jun;129(6):906.e1-906.e10. doi: 10.1016/j.prosdent.2023.03.018. Epub 2023 Apr 16.
- Background: PubMed 27692577Heimer S, Schmidlin PR, Roos M, Stawarczyk B. Surface properties of polyetheretherketone after different laboratory and chairside polishing protocols. J Prosthet Dent. 2017 Mar;117(3):419-425. doi: 10.1016/j.prosdent.2016.06.016. Epub 2016 Sep 28.
- Background: PubMed 39551812Chen Y, Liu W, Wu Z, Wang S, Li Y, Su B, Li S. Advantages and feasibility of prefabricated PEEK crowns for aesthetic restoration in primary teeth. Sci Rep. 2024 Nov 18;14(1):28398. doi: 10.1038/s41598-024-79306-1.
- Background: PubMed 23564476Stawarczyk B, Beuer F, Wimmer T, Jahn D, Sener B, Roos M, Schmidlin PR. Polyetheretherketone-a suitable material for fixed dental prostheses? J Biomed Mater Res B Appl Biomater. 2013 Oct;101(7):1209-16. doi: 10.1002/jbm.b.32932. Epub 2013 Apr 6.
- Background: PubMed 30531169Skirbutis G, Dzingute A, Masiliunaite V, Sulcaite G, Zilinskas J. PEEK polymer's properties and its use in prosthodontics. A review. Stomatologija. 2018;20(2):54-58.
- BackgroundNagarathna, C., Deepthi, L., & Cam, C. A. D. (2026). Next Generation Smile Solutions - PEEK Crowns in Pediatric Dentistry. Journal of Chemical Health Risks, 16(1), 1734-1742.
- Individual participant dataSharing planned: No
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.
Bushra Munzer Shamma, MSc, DDS. principal investigator
Damascus University
Mohannad Laflouf, PhD, MSc, DDS. study chair
Damascus University
Saleh Al Kurdi, PhD, MSc, DDS. study director
Arab International 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 Prefabricated CAD/CAM PEEK with 0.2 mm thickness, Prefabricated CAD/CAM PEEK with 0.4 mm thickness and CAD/CAM-fabricated PEEK Crowns in people with Dental Esthetic, Dental Care for Children, Dental Crowns, run by Arab International University at 1 site in Syria.
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 4 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: finished, as of the sponsor's last update on 28 Oct 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 Syria. 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 Index (time frame: Baseline, 3 months, 6 months, and 12 months postoperatively). The study lists 4 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 NCT07618871, which also lists 6 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 28 Oct 2026.