NCT06682559

Brief Summary

The aim of this randomized clinical trial is to evaluate the volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg in comparison to customized healing abutment.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 5, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

November 4, 2024

Last Update Submit

August 2, 2025

Conditions

Keywords

Dental implantssingle missing posterior teethperi-implant soft tissues

Outcome Measures

Primary Outcomes (1)

  • Measurement of peri-implant soft tissues volume

    Each participant will undergo volumetric analysis of peri-implant soft tissues after 3 months healing either after using prefabricated healing abutment with scan peg in comparison to customized healing abutment using a 3D meteorology software (GOM inspect). It will be measured in millimeter cube

    3 months

Study Arms (2)

Prefabricated healing abutment with scan peg (Neoss implant system, Harrogate, England)

EXPERIMENTAL

12 participants will receive single posterior implants by fully guided implant protocol followed by placement of prefabricated healing abutment with scan peg having convex emergence profile

Other: Prefabricated healing abutment with scan peg

Customized healing abutment

ACTIVE COMPARATOR

12 participants will receive single posterior implants by fully guided implant protocol followed by placement of custom healing abutment having concave emergence profile

Other: Customized healing abutment

Interventions

12 participants will receive single posterior implants by fully guided implant protocol followed by placement of prefabricated healing abutment with scan peg having convex emergence profile

Prefabricated healing abutment with scan peg (Neoss implant system, Harrogate, England)

12 participants will receive single posterior implants by fully guided implant protocol followed by placement of custom healing abutment having concave emergence profile

Customized healing abutment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:
  • Proper bone height and width.
  • Adequate zone of keratinized tissue (at least 2 mm)

You may not qualify if:

  • Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases
  • Pregnancy and Lactation
  • A history of head and neck radiation treatment.
  • Chronic periodontal diseases.
  • Poor oral hygiene (Silness-Löe plaque index score 2 and 3)
  • Parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location

Study Officials

  • Mervat E Abdellah

    Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Statistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 12, 2024

Study Start

November 1, 2024

Primary Completion

May 1, 2025

Study Completion

October 1, 2025

Last Updated

August 5, 2025

Record last verified: 2025-08

Locations