NCT07536451

Brief Summary

Good quality soft tissue determines the possibility not only to obtain full primary wound closure during the bone defect reconstruction, but also assures effective implant treatment and stability of peri-implant condition.Moreover, it is very important to assure the proper emergence profile of the implant supported restorations, which give the opportunity to achieve the highest aesthetic appearance. In the long-term, the correct width and thickness of the attached keratinized tissue is the key point to ensure the stable position of the mucosal line around the implant's neck. The promising outcomes of laser on soft and hard tissue have been demonstrating in a variety of studies. Therefore, the aim of this clinical study is to evaluate the efficacy of LLDLT on enhancing osseointegration and on the peri-implant mucosal tissue around delayed dental implants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 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

June 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 11, 2026

Last Update Submit

April 11, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in marginal bone loss

    To assess the change in marginal bone loss, the linear distance from a fixed reference point-typically the implant shoulder or CEJ-to the highest level of bone-to-tooth/implant contact is measured.

    2 weeks, 1month, 2 months, and 6 months

  • Change in in implant stability

    Ostell device will be used to assess implant stability

    Immediately after surgery, 2 months and 6months postoperative.

Secondary Outcomes (1)

  • Change in bone density

    2 weeks, 1month, 2 months, and 6 months

Study Arms (2)

With laser

EXPERIMENTAL
Other: Dental implant + LLDL

Without laser

ACTIVE COMPARATOR
Other: Dental implant

Interventions

implant placement in the posterior areas and implants will be placed with application of LLDL. Preparation of the alveolus for delayed dental implant placement will be done and LLDL application according to manufacturer instructions

With laser

It includes ten patients seeking for implant placement at the posterior areas and those patients will be received their implants only without application of LLDL .

Without laser

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients are systemically medically free.
  • Ability to maintain good oral hygiene as evidenced in recall visits.
  • Sufficient mesiodistal and interocclusal space and have an intact buccal bone contours which does not require bone augmentation procedures.
  • Adequate bone quality.
  • Keratinized tissue ≥ 2mm.
  • Thickness of the gingiva ≥ 1 mm.

You may not qualify if:

  • Presence of any systemic disease that could influence the outcome of the therapy.
  • Presence of any risk factor e.g.; smoker, pregnant, lactating patients or any disease affect bone healing.
  • Previous history of periodontal surgical treatment in quadrant selected for the study.
  • Restorations or caries in the area to be treated and non-vital tooth.
  • Adjacent teeth are tilted or rotated.
  • Patients taking medications known to cause affect bone quality.
  • Traumatic occlusion or Para-functional habits such as clenching or bruxism.
  • Participation in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafr El-sheikh University

Kafr Elsheikh, Egypt

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

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

Study Record Dates

First Submitted

April 11, 2026

First Posted

April 17, 2026

Study Start

June 1, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations