Prefabricated CAD/CAM PEEK Crowns For Primary Molars Restoration

NCT07618871 | Active Not Recruiting

• 1 other identifier: 106/SRC/Sep.23.2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dental Esthetic, Dental Care for Children, Dental Crowns

Keywords

Polyetheretherketone; Prefabricated crowns; CAD/CAM; Stainless steel crowns

Outcome Measures

Primary Outcomes (4)

• Gingival Index

  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.

  Baseline, 3 months, 6 months, and 12 months postoperatively

• Plaque Index

  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.

  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.

  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.

  Baseline, 3 months, 6 months, 12 months postoperatively

Secondary Outcomes (4)

• Color Stability

  3 months, 6 months, 12 months postoperatively

• Restoration retention and integrity

  3 months, 6 months, 12 months postoperatively

• Marginal Adaptation

  3 months, 6 months, 12 months postoperatively

• Patient/Parent Satisfaction

  3 months, 6 months, 12 months postoperatively

Study Arms (4)

Prefabricated PEEK crowns of 0.2 mm thickness

EXPERIMENTAL

Minimally prepared teeth restored with prefabricated PEEK crowns of 0.2 mm wall thickness.

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.

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.

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.

Procedure: Satinless steel crowns

Interventions

Prefabricated CAD/CAM PEEK with 0.2 mm thickness PROCEDURE

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 PEEK crowns of 0.2 mm thickness

Prefabricated CAD/CAM PEEK with 0.4 mm thickness PROCEDURE

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.

Prefabricated PEEK crowns of 0.4 mm wall thickness

CAD/CAM-fabricated PEEK Crowns PROCEDURE

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.

CAD/CAM-fabricated PEEK crowns

Satinless steel crowns PROCEDURE

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

Stainless steel crowns

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Root resorption exceeding the apical third.
• Non-restorable teeth.
• Presence of swelling, fistula, or acute or chronic pulpitis.

Sponsors & Collaborators

• Arab International University: lead
• Damascus University: collaborator

Study Sites (1)

School of Dental Medicine

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 37072286 BACKGROUND

• Heimer 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.

  PMID: 27692577 BACKGROUND

• Chen 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.

  PMID: 39551812 BACKGROUND

• Stawarczyk 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.

  PMID: 23564476 BACKGROUND

• Skirbutis 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.

  PMID: 30531169 BACKGROUND

• Nagarathna, 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.

  BACKGROUND

Study Officials

• Bushra Munzer Shamma, MSc, DDS.

  Damascus University

  PRINCIPAL INVESTIGATOR

• Mohannad Laflouf, PhD, MSc, DDS.

  Damascus University

  STUDY CHAIR

• Saleh Al Kurdi, PhD, MSc, DDS.

  Arab International University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 1, 2026
• Study Start: April 2, 2024
• Primary Completion: December 10, 2025
• Study Completion (Estimated): August 26, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)