Post-operative PainNCT02711501
Comparison of Post-operative Complications of Bone Augmentation at Anterior of Maxilla After Periosteal Releasing Incision With Two Techniques Diode Laser and Scalpel
A study testing Laser-assisted surgery. and conventional surgery by blade in people with Post-operative Pain, run by Tehran University of Medical Sciences at 3 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Laser-assisted surgery. and conventional surgery by blade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesIran
- Study dates
- Mar 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with the need for a single-tooth replacement in the maxilla by implant and simultaneous GBR
Who cannot join
- general contraindication for bone augmentation or implant surgeries,
- existence of swelling or pain at the time of surgery,
- smoking habits, pregnancy, and lactation.
Trial locations and contacts
3 sites in 1 country.
Iran3 sites
Tehran University of Medical Sciences
Tehran, Tehran Province, 141555583
Neda Moslemi
Tehran, Tehran Province
Tehran University of Medical Sciences
Tehran, Tehran Province
About this study
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.
Read the detailed description
Guided bone regeneration (GBR) is a well established method to augment excessive alveolar bone loss before and at the time of implant placement. Primary closure of soft tissue is a prerequisite for successful bone augmentation procedures. Adequate flap advancement is a key factor for tension free primary wound closure. The tension free flap is usually attained by incising the buccal flap using scalpels. However, this procedure, especially in cases with major flap advancement, results in increased patient morbidity after surgery. Swelling and hemorrhage during the first week after surgery have a negative effect on patient's quality of life.
Currently, lasers are widely used as a tool for soft tissue management and diode laser appears to be an effective tool for incision and excision of the soft tissue. The major advantageous property of lasers is ablation of tissue together with effective hemostasis, minimal swelling and virtually no pain.
- Conditions
- Post-operative Pain
- Being tested
- Laser-assisted surgery., conventional surgery by blade
- Keywords
- post-operative pain, diode laser
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-assisted surgery.Procedure or surgery
laser-assisted surgery
conventional surgery by bladeProcedure or surgery
conventional surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Laser-assisted surgery. |
| blade | Experimental | conventional surgery by blade Receives: Procedure: conventional surgery by blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within the first 6 days after surgery
Secondary outcomes (2)
post-operative pain intensity
Postoperative pain was measured using a visual analog scale (VAS) ranging from zero for "no pain" to 100 for "the worst possible pain".(questionnaire)
Measured: Within the first 6 days after surgery
implant success
based on Albrektsson success criteria.
Measured: 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neda Moslemi, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711501
- Sponsor's protocol ID
- TehranUMS h4p62mb2
- Status last verified
- Sep 2016
- First submitted
- 4 Feb 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Complications of Bone Augmentation at Anterior of Maxilla After Periosteal Releasing Incision With Two Techniques Diode Laser and Scalpel
- ClinicalTrials.gov ID
- NCT02711501
- Acronym / sponsor ID
- TehranUMS h4p62mb2
- Conditions
- Post-operative Pain
- Keywords
- post-operative pain, diode laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Guided bone regeneration (GBR) is a well established method to augment excessive alveolar bone loss before and at the time of implant placement. Primary closure of soft tissue is a prerequisite for successful bone augmentation procedures. Adequate flap advancement is a key factor for tension free primary wound closure. The tension free flap is usually attained by incising the buccal flap using scalpels. However, this procedure, especially in cases with major flap advancement, results in increased patient morbidity after surgery. Swelling and hemorrhage during the first week after surgery have a negative effect on patient's quality of life.
Currently, lasers are widely used as a tool for soft tissue management and diode laser appears to be an effective tool for incision and excision of the soft tissue. The major advantageous property of lasers is ablation of tissue together with effective hemostasis, minimal swelling and virtually no pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser irradiation | Experimental | Procedure: Laser-assisted surgery.laser-assisted surgery with the following parameters: Wavelength:810 nanometer, power: 3 W, pulse mode,pulse length 100 µs, pulse interval 200 µs |
| blade | Experimental | Procedure: conventional surgery by bladeconventional surgery by blade |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with the need for a single-tooth replacement in the maxilla by implant and simultaneous GBR
Key exclusion criteria (3 listed)
- general contraindication for bone augmentation or implant surgeries,
- existence of swelling or pain at the time of surgery,
- smoking habits, pregnancy, and lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser-assisted surgery.laser-assisted surgery | Procedure or surgery | Laser irradiation |
| conventional surgery by bladeconventional surgery | Procedure or surgery | blade |
Primary outcome
post-operative swelling intensity
Time frame: Within the first 6 days after surgery
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).
2 secondary outcomes
post-operative pain intensity
Time frame: Within the first 6 days after surgery
implant success
Time frame: 3 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser-assisted surgery. and conventional surgery by blade in people with Post-operative Pain, run by Tehran University of Medical Sciences at 3 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative swelling intensity (time frame: Within the first 6 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.