NCT02711501

Brief Summary

The aim of this study was to investigate if using lasers instead of scalpel for flap advancement in bone augmentation procedures would reduce post-operative swelling and pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

February 4, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1 month

First QC Date

February 4, 2016

Last Update Submit

September 10, 2016

Conditions

Post-operative Pain

Keywords

post-operative paindiode laser

Outcome Measures

Primary Outcomes (1)

  • post-operative swelling intensity

    Swelling on the operated side was evaluated as follows: 0 (none: no inflammation), 1 (mild: intraoral swelling confined to the surgical field), 2 (moderate: extra oral swelling in the surgical zone), or 3 (intense: extra oral swelling spreading beyond the surgical zone).

    Within the first 6 days after surgery

Secondary Outcomes (2)

  • post-operative pain intensity

    Within the first 6 days after surgery

  • implant success

    3 months later

Study Arms (2)

Laser irradiation

EXPERIMENTAL

laser-assisted surgery with the following parameters: Wavelength:810 nanometer, power: 3 W, pulse mode,pulse length 100 µs, pulse interval 200 µs

Procedure: Laser-assisted surgery.

blade

EXPERIMENTAL

conventional surgery by blade

Procedure: conventional surgery by blade

Interventions

Laser-assisted surgery.PROCEDURE

laser-assisted surgery

Laser irradiation
conventional surgery by bladePROCEDURE

conventional surgery

blade

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with the need for a single-tooth replacement in the maxilla by implant and simultaneous GBR

You may not qualify if:

  • general contraindication for bone augmentation or implant surgeries,
  • existence of swelling or pain at the time of surgery,
  • smoking habits, pregnancy, and lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tehran University of Medical Sciences

Tehran, Tehran Province, 141555583, Iran

Location

Neda Moslemi

Tehran, Tehran Province, Iran

Location

Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 4, 2016

First Posted

March 17, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

IR(3)