NCT07748494

Brief Summary

This study aimed to evaluate bone and soft tissue changes clinically and radio-graphically after using socket sealing abutment with or without bone graft material.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

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

February 15, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
Last Updated

September 15, 2026

Status Verified

December 1, 2025

Enrollment Period

Same day

First QC Date

December 20, 2025

Last Update Submit

September 12, 2026

Conditions

Keywords

Immediate implantSocket sealingSoft tissueImplant stabilityCone beam computed tomography

Outcome Measures

Primary Outcomes (1)

  • soft tissue changes

    Optical scans of the patients' impressions were obtained immediately after surgery (baseline) and at 3- and 6-month follow-up intervals. For each patient, the baseline STL file was digitally superimposed onto the corresponding 3- and 6-month STL files using dedicated image analysis software to evaluate changes in the peri-implant soft tissues over time. A standardized two-dimensional bucco-lingual cross-sectional image was generated along the long axis of the implant. Buccal and lingual/palatal soft tissue dimensional changes were assessed by measuring the linear distance between baseline and follow-up(3,6month) soft tissue profiles at 1, 2, 3, and 4 mm apical to the GM. Mid-buccal gingival recession was evaluated by measuring the vertical change in the position of the gingival margin at 3,6month.

    Baseline,3 month,6month

Secondary Outcomes (1)

  • Dental implant stability assessed by resonance frequency analysis (ISQ)

    basline 3,6 months

Study Arms (2)

With Grafting Material

EXPERIMENTAL

Placement of immediate molar implant followed by socket sealing abutment and addition of grafting material to the extraction socket.

Procedure: Immediate Molar Implant Placement with Grafting Material

Without Grafting Material

ACTIVE COMPARATOR

Placement of immediate molar implant followed by socket sealing abutment without adding grafting material.

Procedure: Immediate Molar Implant Placement without Grafting Material

Interventions

Participants will receive immediate molar implant placement after tooth extraction. A socket sealing abutment will be placed, and the extraction socket will be filled with an appropriate grafting material to promote bone preservation and enhance soft tissue healing. Standard post-operative care will be provided.

With Grafting Material

Participants will receive immediate molar implant placement after tooth extraction. A socket sealing abutment will be placed, without adding any grafting material. Standard post-operative care will be provided.

Without Grafting Material

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with non-restorable maxillary or mandibular molars indicated for extraction and replacement with implants
  • Age between 18-45 years
  • Sufficient inter-arch space to accommodate the future prosthesis
  • Good oral hygiene
  • Free from systemic diseases
  • Patients with jumping space \> 2 mm

You may not qualify if:

  • Presence of any pathological lesion or root tips at the planned surgical site
  • Aggressive periodontal disease
  • Inadequate bone height or thickness for implant placement
  • Alcohol or drug abuse
  • Systemic diseases that contraindicate implant placement (e.g., osteoporosis, active cancer)
  • Pregnancy
  • Para-functional habits (e.g., bruxism, clenching)
  • Patients wearing orthodontic appliances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry ,Mansoura university, Cairo

Al Mansurah, 35516, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2025

First Posted

August 5, 2026

Study Start

February 15, 2024

Primary Completion

February 15, 2024

Study Completion

August 30, 2025

Last Updated

September 15, 2026

Record last verified: 2025-12

Locations