Altered Passive Eruption of TeethNCT04219436
The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability
A study testing vertical mattress suturing technique and figure of eight suturing technique in people with Altered Passive Eruption of Teeth, run by Ain Shams University at 1 site in Egypt.
Trial summary
Gummy smile is one of the major esthetic problems nowadays; it is due to several causes that either dental or skeletal. Etiology of the gummy smile is altered passive eruption, vertical maxillary excess, different gingival enlargement conditions, deficient maxillary lip length and excessive maxillary lip mobility… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Altered Passive Eruption of Teeth
- What is being tested?
- vertical mattress suturing technique and figure of eight suturing technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 Nov 2019
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients complaining from gummy smile (altered passive eruption)
- Bone level is 2 mm or less from the cemento enamel junction
- Teeth included were free from any periodontal destruction
- Good compliance with the plaque control instructions following initial therapy.
- Availability for follow up and maintenance program
Who cannot join
- Presence of systemic diseases which could influence the outcome of the therapy (American society of anesthesiologists I, ASA I).
- Patient suffering from periodontitis stage 4 grade c.
- Presence of smoking habit.
- Presence of occlusion interference.
- Pregnant females and lactating females. .
- Vulnerable groups of patients (handicapped, mentally retarded, prisoners).
- Restored teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability After Esthetic Crown Lengthening for Treatment of Gummy Smile (Randomized Clinical Trial)
Gummy smile is one of the major esthetic problems nowadays; it is due to several causes that either dental or skeletal. Etiology of the gummy smile is altered passive eruption, vertical maxillary excess, different gingival enlargement conditions, deficient maxillary lip length and excessive maxillary lip mobility, dento alveolar extrusion, combination of all these factors.
Altered passive eruption is considered to be one of the most major causes, it is classified into two types according to the location of the mucogingival junction with respect to the bone crest and each type has two subtypes . Esthetic crown lengthening is the treatment of choice for subtype B in both types as bone removal is mandatory to create a space for the biological width.
Read more
Most of the studies stated that there is some degree of relapse of the gingival tissues after the procedures in the follow ups, that relapse was related to the biotype of the gingival tissues, the flap placement close or far from the bone can be correlated to the suturing technique used for closure of the tissues.
In the investigator's study comparing of two different suturing technique was done to evaluated their effect on gingival tissue relapse, 30 patients (26 females and 4 males) were divided between 2 groups each group consisted of 15 patients. In the first group periosteal suturing technique was done in the second figure of eight (modified interrupted) suturing technique was.
Evaluation of the tissue relapse was done through the assessment of the amount of the attached gingival tissues level of gingival margin and marginal tissue contour before and after the surgery.
The results of the study showed that tissue relapse was more in the periosteal suturing technique group that was related to the pressure on the tissues due to the fixation of the suture at the periostium, the papillary tissue also showed more inflammation in the follow up period prior to suture removal. The figure of eight group showed less relapse and tissue inflammation as it prevents flap edge overlap and is tension free therefore better blood supply to the tissue.
Patients were generally satisfied post-surgical with their smile, gingival tissue visibility and teeth dimensions inspite of the relapse but it was better than prior to surgery. Also they would recommend it to other patients complaining from the same problem.
Read the detailed description
Thirty patients (26 females, 4 males), who were candidates for esthetic crown lengthening, participated in this prospective clinical trial.
Group I (15 patients) (vertical mattress suturing technique) :
Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then External vertical mattress suture was done (periosteal suture).
Group II (15 patients) (Figure of eight suturing technique) :
Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then modified interrupted suture was done (Figure of eight suture).
- Conditions
- Altered Passive Eruption of Teeth
- Being tested
- vertical mattress suturing technique, figure of eight suturing technique
- Keywords
- esthetic crown lengthening, suturing technique, vertical mattress suturing technique, figure of eight suturing technique, tissue rebound, supracrestal gingival tissue, free gingival margin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vertical mattress suturing techniqueProcedure or surgery
vertical mattress suturing technique used for flap closure after esthetic crown lengthening
figure of eight suturing techniqueProcedure or surgery
figure of eight suturing technique used for flap closure after esthetic crown lengthening
| Study group | Role | What they receive |
|---|---|---|
| vertical mattress suturing technique | Active comparator | vertical mattress suturing technique is done to close the flap Receives: Procedure: vertical mattress suturing technique |
| figure of eight suturing technique | Active comparator | figure of eight suturing technique is done to close the flap Receives: Procedure: figure of eight suturing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the marginal soft tissue levels rebound
determination of soft tissue rebound: is measured as the difference between (the level of free gingival margin after suturing) and (the level of the free gingival margin 6 months post surgical) both measured from fixed reference point on the stent to the free gingival margin
Measured: 6 months
Secondary outcomes (2)
Supracrestal gingival tissue
the difference between the bone level and the free gingival margin (measured from a fixed reference point on the stent)
Measured: 6 months
Patient satisfaction
questionnaire (After surgery)
- Is the patient satisfied with the gingival display during talking and smiling, teeth display during talking and smiling (not at all, slightly, somewhat, very and extremely).
- How was the procedure experience (much worse, worse, same as I thought, better and much better).
Measured: at 6 months post surgical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Altered Passive Eruption of TeethStudies 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
- Model description
- 2 arms undergoing the same surgical procedure but with different suturing techniques for flap closure
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hesham Mohamed, Ain Shams University
- Investigators
- ahmed gamal, professor, Study director, faculty of dentistry ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219436
- Sponsor's protocol ID
- PER16-35M
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2019
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: when the study is done the results will be published with the protocol
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability After Esthetic Crown Lengthening for Treatment of Gummy Smile (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04219436
- Acronym / sponsor ID
- PER16-35M
- Conditions
- Altered Passive Eruption of Teeth
- Keywords
- esthetic crown lengthening, suturing technique, vertical mattress suturing technique, figure of eight suturing technique, tissue rebound, supracrestal gingival tissue, free gingival margin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 7 Jan 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.
Gummy smile is one of the major esthetic problems nowadays; it is due to several causes that either dental or skeletal. Etiology of the gummy smile is altered passive eruption, vertical maxillary excess, different gingival enlargement conditions, deficient maxillary lip length and excessive maxillary lip mobility, dento alveolar extrusion, combination of all these factors.
Altered passive eruption is considered to be one of the most major causes, it is classified into two types according to the location of the mucogingival junction with respect to the bone crest and each type has two subtypes . Esthetic crown lengthening is the treatment of choice for subtype B in both types as bone removal is mandatory to create a space for the biological width.
Most of the studies stated that there is some degree of relapse of the gingival tissues after the procedures in the follow ups, that relapse was related to the biotype of the gingival tissues, the flap placement close or far from the bone can be correlated to the suturing technique used for closure of the tissues.
In the investigator's study comparing of two different suturing technique was done to evaluated their effect on gingival tissue relapse, 30 patients (26 females and 4 males) were divided between 2 groups each group consisted of 15 patients. In the first group periosteal suturing technique was done in the second figure of eight (modified interrupted) suturing technique was.
Evaluation of the tissue relapse was done through the assessment of the amount of the attached gingival tissues level of gingival margin and marginal tissue contour before and after the surgery.
The results of the study showed that tissue relapse was more in the periosteal suturing technique group that was related to the pressure on the tissues due to the fixation of the suture at the periostium, the papillary tissue also showed more inflammation in the follow up period prior to suture removal. The figure of eight group showed less relapse and tissue inflammation as it prevents flap edge overlap and is tension free therefore better blood supply to the tissue.
Patients were generally satisfied post-surgical with their smile, gingival tissue visibility and teeth dimensions inspite of the relapse but it was better than prior to surgery. Also they would recommend it to other patients complaining from the same problem.
Detailed description
Thirty patients (26 females, 4 males), who were candidates for esthetic crown lengthening, participated in this prospective clinical trial.
Group I (15 patients) (vertical mattress suturing technique) :
Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then External vertical mattress suture was done (periosteal suture).
Group II (15 patients) (Figure of eight suturing technique) :
Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then modified interrupted suture was done (Figure of eight suture).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arms undergoing the same surgical procedure but with different suturing techniques for flap closure
| Arm | Type | Receives |
|---|---|---|
| vertical mattress suturing technique | Active comparator | Procedure: vertical mattress suturing techniquevertical mattress suturing technique is done to close the flap |
| figure of eight suturing technique | Active comparator | Procedure: figure of eight suturing techniquefigure of eight suturing technique is done to close the flap |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients complaining from gummy smile (altered passive eruption)
- Bone level is 2 mm or less from the cemento enamel junction
- Teeth included were free from any periodontal destruction
- Good compliance with the plaque control instructions following initial therapy.
- Availability for follow up and maintenance program
Key exclusion criteria (7 listed)
- Presence of systemic diseases which could influence the outcome of the therapy (American society of anesthesiologists I, ASA I).
- Patient suffering from periodontitis stage 4 grade c.
- Presence of smoking habit.
- Presence of occlusion interference.
- Pregnant females and lactating 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 |
|---|---|---|
| vertical mattress suturing techniquevertical mattress suturing technique used for flap closure after esthetic crown lengthening | Procedure or surgery | vertical mattress suturing technique |
| figure of eight suturing techniquefigure of eight suturing technique used for flap closure after esthetic crown lengthening | Procedure or surgery | figure of eight suturing technique |
Primary outcome
evaluation of the marginal soft tissue levels rebound
Time frame: 6 months
determination of soft tissue rebound: is measured as the difference between (the level of free gingival margin after suturing) and (the level of the free gingival margin 6 months post surgical) both measured from fixed reference point on the stent to the free gingival margin
2 secondary outcomes
Supracrestal gingival tissue
Time frame: 6 months
Patient satisfaction
Time frame: at 6 months post surgical
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 Jan 2025.
- Individual participant dataSharing planned: Yes. when the study is done the results will be published with the protocol
Related trials for Altered Passive Eruption of Teeth
Enrolling by invitation
Laser-Assisted Minimally Invasive Esthetic Crown Lengthening Using Flapless vs. Tunneled Flap Approach
Altered Passive Eruption of Teeth
RecruitingObservational study
Gummy Smile and Altered Passive Eruption Prevalence
Altered Passive Eruption of Teeth
Active, not recruiting
Clinical Evaluation of Gingivalstat Approach Compared to Conventional Esthetic Crown Lengthening on the Stability of The Gingival Margin in Patients With Altered Passive Eruption.
Gummy Smile, Altered Passive Eruption of Teeth
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.
ahmed gamal, professor study director
faculty of dentistry ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vertical mattress suturing technique and figure of eight suturing technique in people with Altered Passive Eruption of Teeth, run by Ain Shams 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 5 inclusion and 7 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 Jan 2025. 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?
evaluation of the marginal soft tissue levels rebound (time frame: 6 months). 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 Jan 2025.