Pain, PostoperativeNCT04542486
Clinical Efficacy of Soft Tissue Trimmer in Cases of Gingival Hyperplasia.
A study testing Excision of gingival hyperplasia using "Soft tissue trimmer ". and Excision of gingival hyperplasia using the conventional scalpel technique in people with Pain, Postoperative and Wound Heal, run by Cairo University at 1 site in Egypt.
Trial summary
Postoperative pain and wound healing are compared after using conventional scalpel technique in comparison with the intervention which is using Soft tissue Trimmer for cases of gingival hyperplasia. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Wound Heal, Gingival Hyperplasia
- What is being tested?
- Excision of gingival hyperplasia using "Soft tissue trimmer ". and Excision of gingival hyperplasia using the conventional scalpel technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2021to 1 Jul 2021
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Anterior region (minimum of four teeth at each surgical site)
- Age range (18-45) years old
- Plaque-induced inflammatory gingival enlargement
- Altered passive eruption
- No clinical attachment loss
- Systemically healthy individuals
Who cannot join
- Gingival enlargement due to any systemic predisposing factors
- Pregnancy and/or lactation
- Allergy
- Conditions requiring antibiotic prophylaxis and anti-inflammatory medications.
- Acute or untreated periodontitis
- Systemic disease that could influence the outcome of the treatment (i.e. Diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Soft Tissue Trimmer on Postoperative Pain and Wound Healing When Compared to the Conventional Surgical Excision of Gingival Hyperplasia: A Randomized Clinical Trial
Postoperative pain and wound healing are compared after using conventional scalpel technique in comparison with the intervention which is using Soft tissue Trimmer for cases of gingival hyperplasia.
Read the detailed description
In the control group:
- Following the local anaesthetic administration, A reverse bevel gingivectomy will be performed with a #15c scalpel.
- The borderline of gingiva will be determined via the use of a pointer dental tweezers, and excessive gingival tissue will then be removed with Gracey curettes
- No periodontal packs to be applied to ensure accurate evaluations of follow-up pain and wound healing
In the intervention group:
- Following the local anaesthetics administration for the Soft tissue trimmer(STT) gingivectomies, Soft tissue trimmer will be used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation.
- Gingivoplasties will be performed with the same Soft tissue trimmer to easily provide a knife-edge appearance.
- No periodontal packs will be applied to ensure accurate evaluations of follow-up pain and wound healing.
- Conditions
- Pain, Postoperative, Wound Heal, Gingival Hyperplasia
- Being tested
- Excision of gingival hyperplasia using "Soft tissue trimmer "., Excision of gingival hyperplasia using the conventional scalpel technique
- Medical subject headings
- Pain, Postoperative, Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision of gingival hyperplasia using "Soft tissue trimmer ".Procedure or surgery
Gingivoplasties and removal of excess gingival tissues using Soft tissue trimmer.
Excision of gingival hyperplasia using the conventional scalpel techniqueProcedure or surgery
Excision of gingival hyperplasia in gingivoplasties using the conventional technique reverse bevel using 15c blade.
| Study group | Role | What they receive |
|---|---|---|
| The conventional approach: | Experimental | Gingivoplasties and removal of excess gingival tissues through the conventional scalpel technique using a reverse bevel. Receives: Procedure: Excision of gingival hyperplasia using the conventional scalpel technique |
| The intervention approach: | Active comparator | Gingivoplasties and elimination of excess gingival tissues through the use of "Soft tissue trimmer". Receives: Procedure: Excision of gingival hyperplasia using "Soft tissue trimmer ". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS
Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured 1,3,5 and 7 days postoperatively.
Measured: 7 days
Secondary outcomes (4)
Epithelization
Re-epithelization after removal of excess tissue will be assessed either partial or complete.This will be tested by toluidine blue (TB)
Measured: 14 days.
Tissue colour
If it is either redder or whiter than the opposite side, or like opposite side tissue.
Measured: 6 weeks.
Bleeding
If bleeding spontaneously or on palpation exists or not.
Measured: From 3-5 days
Surgical time
Time taken for both groups of surgery( control and intervention) will be measured from the administration of anaesthesia till removal of excess tissues.
Measured: During surgical procedure itself.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start28 Jan 2021
- Primary completion1 Mar 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed Sameh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542486
- Sponsor's protocol ID
- PER 3-3-1
- Status last verified
- Apr 2022
- First submitted
- 2 Sep 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Soft Tissue Trimmer on Postoperative Pain and Wound Healing When Compared to the Conventional Surgical Excision of Gingival Hyperplasia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04542486
- Acronym / sponsor ID
- PER 3-3-1
- Conditions
- Pain, Postoperative, Wound Heal, Gingival Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 9 Sep 2020 (actual)
- 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.
Postoperative pain and wound healing are compared after using conventional scalpel technique in comparison with the intervention which is using Soft tissue Trimmer for cases of gingival hyperplasia.
Detailed description
In the control group:
- Following the local anaesthetic administration, A reverse bevel gingivectomy will be performed with a #15c scalpel.
- The borderline of gingiva will be determined via the use of a pointer dental tweezers, and excessive gingival tissue will then be removed with Gracey curettes
- No periodontal packs to be applied to ensure accurate evaluations of follow-up pain and wound healing
In the intervention group:
- Following the local anaesthetics administration for the Soft tissue trimmer(STT) gingivectomies, Soft tissue trimmer will be used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation.
- Gingivoplasties will be performed with the same Soft tissue trimmer to easily provide a knife-edge appearance.
- No periodontal packs will be applied to ensure accurate evaluations of follow-up pain and wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The conventional approach: | Experimental | Procedure: Excision of gingival hyperplasia using the conventional scalpel techniqueGingivoplasties and removal of excess gingival tissues through the conventional scalpel technique using a reverse bevel. |
| The intervention approach: | Active comparator | Procedure: Excision of gingival hyperplasia using "Soft tissue trimmer ".Gingivoplasties and elimination of excess gingival tissues through the use of "Soft tissue trimmer". |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Anterior region (minimum of four teeth at each surgical site)
- Age range (18-45) years old
- Plaque-induced inflammatory gingival enlargement
- Altered passive eruption
- No clinical attachment loss
Key exclusion criteria (6 listed)
- Gingival enlargement due to any systemic predisposing factors
- Pregnancy and/or lactation
- Allergy
- Conditions requiring antibiotic prophylaxis and anti-inflammatory medications.
- Acute or untreated periodontitis
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 |
|---|---|---|
| Excision of gingival hyperplasia using "Soft tissue trimmer ".Gingivoplasties and removal of excess gingival tissues using Soft tissue trimmer. | Procedure or surgery | The intervention approach: |
| Excision of gingival hyperplasia using the conventional scalpel techniqueExcision of gingival hyperplasia in gingivoplasties using the conventional technique reverse bevel using 15c blade. | Procedure or surgery | The conventional approach: |
Primary outcome
Pain VAS
Time frame: 7 days
Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured 1,3,5 and 7 days postoperatively.
4 secondary outcomes
Epithelization
Time frame: 14 days.
Tissue colour
Time frame: 6 weeks.
Bleeding
Time frame: From 3-5 days
Surgical time
Time frame: During surgical procedure itself.
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 Apr 2022.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision of gingival hyperplasia using "Soft tissue trimmer ". and Excision of gingival hyperplasia using the conventional scalpel technique in people with Pain, Postoperative and Wound Heal, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 6 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 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Pain VAS (time frame: 7 days). 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 Apr 2022.