Pain, PostoperativeNCT04401826
Micro-surgical Treatment of Gummy Smile
A study testing Tunneling micro-surgical crown lengthening approach using piezo-surgery and Micro-surgical crown lengthening approach using Piezosurgery in people with Pain, Postoperative, run by Cairo University at 1 site in Egypt.
Trial summary
Compare pain response following microsurgical conventional flap approach using Piezosurgery versus flapless approach for esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Tunneling micro-surgical crown lengthening approach using piezo-surgery and Micro-surgical crown lengthening approach using Piezosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Sep 2020to 6 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- The presence of the six upper anterior teeth.
- Patients who have short clinical crowns due to altered passive eruption classified as Type I subclass B (Coslet, Vanarsdall and Weisgold, 1977).
- Absence of sites with attachment loss and probing depth (PD) >3 mm.
- Keratinized gingiva of at least 2mm width (Pontoriero and Carnevale, 2001).
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- Compliance with good oral hygiene.
- Patients accepts 6-months follow-up period (cooperative patients).
- Patients provides an informed consent.
Who cannot join
- Presence of prosthetic crowns
- Extensive restorations
- Extensive incisal edge attrition.
- Smokers ˃ 10 cigarettes / day
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pain Following Microsurgical Esthetic Crown Lengthening Using Flap Vs. Flapless Piezo-surgical Approach: A Randomized Controlled Clinical Trial
Compare pain response following microsurgical conventional flap approach using Piezosurgery versus flapless approach for esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.
Read the detailed description
The conventional approach: Anesthesia will be given followed by bone sounding using William graduated periodontal probe and measuring the pocket depth (using magnification loupes and microsurgical blades)
- Marking the bleeding points
- An internal bevel incision is made followed afterwards by a sulcular incision.
- The gingival collar is eliminated.
- Elevation of the flap is proceeded to allow access for osteoplasty using piezo surgery and an apical position of the bone 2-3mm beyond CEJ.
- Mattress suture (6.0) is made
The intervention approach:
Surgery is done the same as in the conventional approach but without opening a flap, gaining access via a tunneling instrument and piezo tips for osteoplasty
- Conditions
- Pain, Postoperative
- Being tested
- Tunneling micro-surgical crown lengthening approach using piezo-surgery, Micro-surgical crown lengthening approach using Piezosurgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunneling micro-surgical crown lengthening approach using piezo-surgeryProcedure or surgery
excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery via tunneling
Micro-surgical crown lengthening approach using PiezosurgeryProcedure or surgery
excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery with conventional flap elevation.
| Study group | Role | What they receive |
|---|---|---|
| The conventional approach | Experimental | Conventionnal ECL using piezosurgery and microsurgical tools Receives: Procedure: Micro-surgical crown lengthening approach using Piezosurgery |
| The intervention approach: | Active comparator | Conventionnal ECL with tunneling using piezosurgery and microsurgical tools Receives: Procedure: Tunneling micro-surgical crown lengthening approach using piezo-surgery |
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 daily for the first 2 days postoperative
Measured: 48 hours
Secondary outcomes (4)
Mid-buccal gingival margin level
Periodontal probe with William's graduation will be used to measure the distance from a prefabricated grooved stent vertically- to the level of the gingival margin at the mid-buccal surface (measured at baseline, 3 and 6 months postoperatively)
Measured: 6 months
Post-Surgical Patient Satisfaction.
Numerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. )
Measured: 6 months
Pink Esthetic Score
The PES is based on seven variables:
mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable shall be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence. All other variables will be assessed by comparison to a reference tooth.
Measured: 6 months
Post-Surgical swelling
Absent: no swelling, Slight: intraoral swelling at the operated area, Moderate: moderate intraoral swelling at the operated area and Intense: intensive extra oral swelling extending beyond the operated area. (Assessed in day 7 and 14 postoperatively)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start6 Sep 2020
- Primary completion6 Dec 2021
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-line Sherif Sourour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401826
- Sponsor's protocol ID
- PER3-3-1
- Status last verified
- Jul 2023
- First submitted
- 21 May 2020
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sourour ML, Tawfik OK, Hosny M, Fawzy El-Sayed KM. Evaluation of minimally invasive esthetic crown lengthening using an open flap versus flapless surgical approach: A randomized controlled clinical trial. J Esthet Restor Dent. 2024 Oct;36(10):1353-1362. doi: 10.1111/jerd.13247. Epub 2024 May 15.
PubMed 38747087
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Following Microsurgical Esthetic Crown Lengthening Using Flap Vs. Flapless Piezo-surgical Approach: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04401826
- Acronym / sponsor ID
- PER3-3-1
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Sep 2020 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 26 May 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.
Compare pain response following microsurgical conventional flap approach using Piezosurgery versus flapless approach for esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.
Detailed description
The conventional approach: Anesthesia will be given followed by bone sounding using William graduated periodontal probe and measuring the pocket depth (using magnification loupes and microsurgical blades)
- Marking the bleeding points
- An internal bevel incision is made followed afterwards by a sulcular incision.
- The gingival collar is eliminated.
- Elevation of the flap is proceeded to allow access for osteoplasty using piezo surgery and an apical position of the bone 2-3mm beyond CEJ.
- Mattress suture (6.0) is made
The intervention approach:
Surgery is done the same as in the conventional approach but without opening a flap, gaining access via a tunneling instrument and piezo tips for osteoplasty
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: Micro-surgical crown lengthening approach using PiezosurgeryConventionnal ECL using piezosurgery and microsurgical tools |
| The intervention approach: | Active comparator | Procedure: Tunneling micro-surgical crown lengthening approach using piezo-surgeryConventionnal ECL with tunneling using piezosurgery and microsurgical tools |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- The presence of the six upper anterior teeth.
- Patients who have short clinical crowns due to altered passive eruption classified as Type I subclass B (Coslet, Vanarsdall and Weisgold, 1977).
- Absence of sites with attachment loss and probing depth (PD) >3 mm.
Key exclusion criteria (5 listed)
- Presence of prosthetic crowns
- Extensive restorations
- Extensive incisal edge attrition.
- Smokers ˃ 10 cigarettes / day
- Pregnant females
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 |
|---|---|---|
| Tunneling micro-surgical crown lengthening approach using piezo-surgeryexcess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery via tunneling | Procedure or surgery | The intervention approach: |
| Micro-surgical crown lengthening approach using Piezosurgeryexcess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery with conventional flap elevation. | Procedure or surgery | The conventional approach |
Primary outcome
Pain VAS
Time frame: 48 hours
Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperative
4 secondary outcomes
Mid-buccal gingival margin level
Time frame: 6 months
Post-Surgical Patient Satisfaction.
Time frame: 6 months
Pink Esthetic Score
Time frame: 6 months
Post-Surgical swelling
Time frame: 14 days
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 5 Jul 2023.
- Derived from this study: PubMed 38747087Sourour ML, Tawfik OK, Hosny M, Fawzy El-Sayed KM. Evaluation of minimally invasive esthetic crown lengthening using an open flap versus flapless surgical approach: A randomized controlled clinical trial. J Esthet Restor Dent. 2024 Oct;36(10):1353-1362. doi: 10.1111/jerd.13247. Epub 2024 May 15.
- Individual participant dataSharing planned: No
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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 Tunneling micro-surgical crown lengthening approach using piezo-surgery and Micro-surgical crown lengthening approach using Piezosurgery in people with Pain, Postoperative, 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 9 inclusion and 5 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 5 Jul 2023. 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: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04401826, which also lists 1 linked publication.
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 5 Jul 2023.