Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations

Dental Implants, Single-Tooth Clinical Trial

Official title:

Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05402202
• Other study ID #: IORG0008831
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized clinical trial is to evaluate the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body

Description:

Evaluation of the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: May 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:

1. Adequate interarch and mesiodistal space.

2. Proper bone height and width.

3. Adequate zone of keratinized tissue (at least 2 mm)

Exclusion Criteria:

1. Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases

2. A history of head and neck radiation treatment.

3. Periodontal diseases.

4. Poor oral hygiene (Silness-Löe plaque index score 2 and 3) (32)

5. Parafunctional habits.

6. Malocclusion.

Related Conditions & MeSH terms

• Dental Implants, Single-Tooth

Intervention

Other:
• Healing abutment with scan peg (Neoss implant system, Harrogate, England)
12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg
• Customized healing abutment
12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment fabricated by intraoral scanning by scan body

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scanning time (healing abutment-scan peg vs scan body)	The scanning time by intraoral scanner will be recorded in both groups	Through study completion, an average of 1 year
Primary	Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body	The proximal contacts will be evaluated with dental floss; Open: an open contact will be reported if there is no resistance against floss; Ideal: an ideal contact will be reported if there is some resistance to interproximal floss insertion.; Tight: a tight contact will be reported if it prevents the passage of floss through the proximal contact point.; The percentage of proximal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.	Through study completion, an average of 1 year
Primary	Quality of occlusal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body	An evaluation of occlusion will be executed with 2 layers of shim stock of 12µ.; No adjustment: if the shimstock is held when the patient clenches and does not need any adjustment.; Mild adjustment: If the shim stock is held after simple closure, the occlusal contact will be reported as heavy and received mild chairside adjustment.; Major adjustment: If the crown is returned to the manufacturing technician, the adjustment is considered major.; Out of occlusion: If the shim stock passes without resistance after clenching, an open contact will be reported.; The percentage of occlusal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.	Through study completion, an average of 1 year
Primary	Evaluation of occlusion by digital occlusal analyzer	occlusal force of implant-supported restorations will be measured	Through study completion, an average of 1 year
Secondary	Peri-implant Probing Depth (scan peg vs customized healing abutment)	Peri-implant probing depth refers to the distance from the gingival margin till the point of least resistance. The peri-implant probing depth will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus.; Measurements will be made at 4 sites around each implant; mesiobuccal, disto-buccal, mesio-palatal and disto-palatal. Probing depth of 1 mm or less will be recorded as 1 mm, and those exceeding 1 mm, but less than 2 mm, will be recorded as 2 mm, and so on. The mean for each implant will be calculated.	up to 6 months
Secondary	Clinical Attachment level (scan peg vs customized healing abutment)	It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level will be performed simultaneously while measuring the peri-implant probing depth.	up to 6 months
Secondary	Modified gingival index (scan peg vs customized healing abutment)	The peri-implant mucosal tissues around the implants will be assessed according to Lobene and Weatherford. The category criteria for assessment will be as follows: 0: Absence of inflammation, normal gingiva.; Mild inflammation, slight color change, little change in texture of any portion of, but not entire, marginal, or papillary gingival unit (localized).; Mild inflammation, slight color change, little change in texture involving the entire or papillary gingival unit (generalized).; Moderate inflammation, redness, and edema.; Severe inflammation, marked redness, edema, ulceration, and spontaneous bleeding It will be measured at 4 sites around each implant (mesially, distally, labially/ buccaly, lingually) then, the mean record will be calculated for each implant.	up to 6 months
Secondary	Marginal bone loss (scan peg vs customized healing abutment)	Periapical digital radiographs will be taken at time of crown insertion (baseline) and up to 6 months later. Changes in the marginal bone level will be evaluated every time using standardized radiographs. To achieve the same orthoradial perspective on the implants, X-ray film positioning devices will be used. After importing screenshots of the radiographs, the amount of bone loss will be measured.	up to 6 months