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Not yet recruitingNCT07044895Updated Jul 1, 2025

Diode Laser Photocoagulation With Immediate Implant Placement

An interventional study of Diode laser and Immediate implant in Tooth Extraction, Immediate Dental Implant and Photocoagulation, sponsored by Hams Hamed Abdelrahman. Not yet recruiting at 1 site in Lebanon. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tooth Extraction
  • Immediate Dental Implant
  • Photocoagulation
  • Maxillary Esthetic Zone
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Immediate implant with photocoagulation

    Other: Diode laser and Immediate implant

Interventions

  • OtherDiode laser and Immediate implant

    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.

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: at 7, 14, and 21 days

  2. 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

    Time frame: at 7, 14, and 21 days

  3. 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.

    Time frame: baseline and 6 months

Secondary outcomes

  1. Change in Crestal Alveolar Process width

    The width of the crestal alveolar process will be assessed by determination of the dimensional changes of Bucco-palatal ridge in the 6 months' scan

    Time frame: baseline and 6 months

  2. Change in labial bone thickness

    The overall persistence of the labial plate of bone after the atraumatic extraction and immediate implant placement will be evaluated by the assessment of the thickness labial plate of bone in the scan performed after 6 months and comparing it with the preoperative CBCT record. The distance will be measured from the root surface to the outer buccal bone surface in the preoperative CBCT record. Measurements will be performed on the cross-sectional cut of the CBCT at three levels; crestal labial thickness, middle labial thickness, and apical labial thickness.

    Time frame: baseline and 6 months

  3. Change in esthetic of soft tissue

    The pink esthetic score (PES) introduced by Furhauser et al will be used for evaluation of the esthetic outcome of soft tissue surrounding single crowns supported by implant in the esthetic zone. The PES consists of seven factors each one is given a score of 2, 1, or 0, and a total score will be ranging between 0 and 14

    Time frame: at 1 month

06

Study locations

1 site
  • Faculty of Dentistry clinics, Beirut Arab University
    Beirut, Lebanon
    • Amina R Ali, BDS · Contact
    • Amina R Ali, BDS · Principal investigator
07

Registry details

Key details

Study ID
NCT07044895
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Lecturer of Dental Public Health and biostatistical consultanat, Alexandria University) — Sponsor-investigator
First posted
Jul 1, 2025
Start date
Jun 30, 2025 (estimated)
Primary completion
Feb 25, 2026 (estimated)
Completion
Feb 25, 2026 (estimated)
Last update
Jul 1, 2025

Study contacts

Amina R Ali, BDS
Contact
dr_aminahweidi2016@hotmail.com
+961 70 908 487

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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