NCT06764732

Brief Summary

laser photo biomodulation (PBM) as a supplement to socket seal surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
Last Updated

January 8, 2025

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

January 3, 2025

Last Update Submit

January 3, 2025

Conditions

Keywords

bio active glasssocket preservation

Outcome Measures

Primary Outcomes (1)

  • alveolar ridge dimensional changes in height and width measures

    at base line and after 9 months

Secondary Outcomes (1)

  • bone biopsy

    after 9 months

Study Arms (3)

control group

PLACEBO COMPARATOR

platelet rich fibrin membrane

Biological: Platelet rich fibrin

test 1 group

EXPERIMENTAL

bioactive glass

Biological: bioactive glassBiological: Platelet rich fibrin

test 2group

ACTIVE COMPARATOR

bioactive glass and Photobiomodulation

Biological: bioactive glassRadiation: bioactive glass graft and PBM irradiationBiological: Platelet rich fibrin

Interventions

bioactive glassBIOLOGICAL

supplied as resorbable form, (400-800um) particle siz

test 1 grouptest 2group

The used laser parameters were set as: wavelength, 980 nm; power, 0.55 W; energy, 36 J; power density, 0.76 W cm2

test 2group

10 ml of blood was withdrawn from the patient and immediately centrifuged for 10 minutes at 3000 revolutions/min and the layer of fibrin clot was obtained

control grouptest 1 grouptest 2group

Eligibility Criteria

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

You may qualify if:

  • Presence of at least a periodontal-affected and non-restorable tooth in posterior region (Class II sockets).
  • At least 10% plaque control scoring was accepted
  • A moderate to thick gingival phenotype

You may not qualify if:

  • systemic diseases or conditions that may compromise healing or bone metabolism,
  • having a history of radiotherapy, chemotherapy or bisphosphonate therapy, previous use of antibiotics in the last 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

, Faculty of Oral and Dental Medicine, Delta University for Science and Technology (DU), Dakahlia, Egypt

Dakahlia, Egypt

Location

Related Publications (1)

  • Hazzaa HH, Shiekh MAME, AbdAllah MF, Abdelgawad N, El-Mahdy MA, Shoshan HS, Elewa GM. Laser-assisted socket seal surgery using bioactive glass for dental implant site development: a randomized clinical trial. Sci Rep. 2025 Dec 9;15(1):43386. doi: 10.1038/s41598-025-28824-7.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 3, 2025

First Posted

January 8, 2025

Study Start

November 10, 2022

Primary Completion

November 10, 2023

Study Completion

February 10, 2024

Last Updated

January 8, 2025

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations