NCT07753044

Brief Summary

Background: Dental implantology offers reliable tooth replacement options, but infections in extraction sockets can compromise osseointegration. Conventional disinfection methods, such as chlorhexidine, often fail to completely eliminate pathogenic microorganisms and may impair tissue healing. Photoactivated disinfection (PAD) and laser disinfection have emerged as promising alternatives. PAD employs a light-activated photosensitizer to generate reactive oxygen species (ROS), effectively disrupting bacterial membranes while preserving host cell viability. In parallel, laser disinfection utilizes focused light energy to eliminate bacterial biofilms and contaminated tissue with minimal thermal damage. In this study, we specifically utilize the Er,Cr:YSGG laser, which operates at a water-absorbing wavelength to induce micro-explosions that mechanically disrupt biofilms and promote a cleaner socket environment for improved osseointegration. Aim of the study: To compare the effectiveness of photoactivated disinfection (PAD), Er,Cr:YSGG laser disinfection, and conventional disinfection with chlorhexidine in decontaminating infected extraction sockets prior to immediate implant placement, promoting bone healing, and improving the osseointegration and stability of immediate implants placed in infected extraction sockets.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

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
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

June 10, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 4, 2026

Last Update Submit

August 4, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • implant stability

    Resonance Frequency Analysis (RFA) using Osstell ISQ: Implant Stability Quotient (ISQ) values will be recorded at 6 months after implant placement. Values from 1 to 100, the higher the ISQ, the higher the stability of the implant.

    6 months

  • change in bone density

    Bone density assessment using radiographs immediately post-operative and at 6 months.

    baseline and 6 months

  • change in marginal bone loss

    Marginal Bone Loss (MBL) assessment using radiographs immediately postoperative and at 6 months.

    baseline and 6 months

Secondary Outcomes (2)

  • change in pain scores

    up to 7 days

  • change in post-operative edema

    up to 7 days

Study Arms (3)

PAD

EXPERIMENTAL
Other: Photoactivated disinfection

Er,Cr:YSGG laser Group

EXPERIMENTAL
Other: Er,Cr:YSGG laser disinfection

Conventional group

ACTIVE COMPARATOR
Other: Chlorohexidine disinfection

Interventions

Standard treatment + Toluidine blue + Light activation + Immediate implant placement

PAD

Standard treatment + Er,Cr:YSGG laser application + Immediate Implant placement

Er,Cr:YSGG laser Group

Standard treatment + Chlorohexidine Irrigation + Immediate Implant placement

Conventional group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients having posterior tooth/teeth indicated for extraction
  • Patients must exhibit radiographic evidence of infection, defined as chronic periapical pathology (radiolucency)
  • The extraction site should have intact surrounding alveolar bone
  • There must be at least 2 mm of sound bone beyond the root apex
  • Patients must be in overall good health and free from uncontrolled systemic conditions

You may not qualify if:

  • History of radiation therapy in the head and neck region
  • Pregnant or lactating women
  • Patients on long-term antibiotic therapy, as it could influence the outcomes
  • Heavy Smoking: More than 10-15 cigarettes per day.
  • Significant bruxism or parafunctional habits affecting implant stability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 7, 2026

Study Start

June 10, 2025

Primary Completion

February 3, 2026

Study Completion

February 3, 2026

Last Updated

August 7, 2026

Record last verified: 2026-08

Locations