NCT07044895

Brief Summary

Placement of an immediate implant is becoming popular because of its potential in minimizing the treatment time and enhancing the patient comfort and esthetic outcomes. It is crucial to maintain adequate thickness of labial bone with the establishment of a stable and healthy gingival seal around the implant abutment to prevent the invasion of bacteria and peri-implant inflammation. Diode lasers have been developed as a promising tool in dentistry, providing a precise manipulation and photocoagulation effect that may have a positive influence on both bone remodeling and soft tissue healing. This study aims to evaluate the effectiveness of the utilization of diode laser photocoagulation with immediate implant placement and customized healing abutment in the maxillary esthetic zone.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

June 22, 2025

Last Update Submit

June 22, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in pain socres

    Pain will be evaluated, using visual analogue scale (VAS) as follows: (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

    at 7, 14, and 21 days

  • Change in wound healing

    The wound healing will be assessed based on Landry Wound Healing Index. The Landry Index uses a numerical score based on the assessment of four given parameters (Erythema, Edema, Wound Margin Adaptation, and Presence of Exudate). Each parameter is given a score depending on its severity, and the total score determine an overall evaluation of wound healing

    at 7, 14, and 21 days

  • Change in implant stability

    The base line primary Implant Stability Quotient (ISQ) will be measured during the operative stage, while the secondary stability quotient will be measured 6-months post-operative during the prosthetic phase preparation.

    baseline and 6 months

Secondary Outcomes (3)

  • Change in Crestal Alveolar Process width

    baseline and 6 months

  • Change in labial bone thickness

    baseline and 6 months

  • Change in esthetic of soft tissue

    at 1 month

Study Arms (1)

Immediate implant with photocoagulation

EXPERIMENTAL
Other: Diode laser and Immediate implant

Interventions

patients with non-restorable teeth in the maxillary esthetic zone will be included in this prospective single-arm study. The non-restorable tooth will be atraumatically extracted and immediate implant placement will be placed. The extraction socket will be sealed with diode laser photocoagulation and customized healing abutments fabrication.

Immediate implant with photocoagulation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with non-restorable maxillary teeth in the aesthetic zone are indicated for extraction and subsequent immediate implant placement, including those with:
  • A severely carious tooth that cannot be restored.
  • Pulpal necrosis or irreversible pulpitis that is not amenable to endodontics.
  • Periodontally involved teeth with grade 2 mobility or above.
  • Teeth with root caries that can't be restored.
  • Patients with an extraction socket Type I.
  • A good standard of oral hygiene.

You may not qualify if:

  • Patients with extraction socket Type II or III, with buccal plate defects.
  • Absence of at least 2 mm of bone apical to the extraction socket
  • tooth ankylosis.
  • Patients with deciduous teeth.
  • Heavy smokers.
  • Systemic conditions
  • History of oral or intravenous bisphosphonate therapy or any treatments with other medications that may interfere with bone metabolism within the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry clinics, Beirut Arab University

Beirut, Lebanon

Location

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

First Submitted

June 22, 2025

First Posted

July 1, 2025

Study Start

June 30, 2025

Primary Completion

February 25, 2026

Study Completion

February 25, 2026

Last Updated

July 1, 2025

Record last verified: 2025-06

Locations