Gingival RecessionNCT03767309
Management of Miller Class I & II Gingival Recession
A study testing coronally advanced flap with abrasive de-epithelized graft. and coronally advanced flap with de-epithelized graft. in people with Gingival Recession, run by Halla Gamal Mohammed Esmail.
Trial summary
Management of Miller class I \& II gingival recession using coronally advanced flap combined with conventional de-epithelialized free gingival graft versus coronally advanced flap combined with abrasive de-epithelized connective tissue graft Null hypothesis: In patients with Miller class I and II gingival recession… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- coronally advanced flap with abrasive de-epithelized graft. and coronally advanced flap with de-epithelized graft.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 1 Dec 2020
- 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
- Age ≥ 18 years.
- Systemically healthy patients.
- Miller's Class I and II recession defects with recession depth ≥ 2mm.
- Presence of identifiable cemento-enamel junction (CEJ).
- Clinical indication and/or patient request for recession coverage.
- Smoking ≤ 10 cigarettes/day.
- Cooperative patients able and accept to come for follow up appointments.
Who cannot join
- Pregnant females.
- Smoking ˃ 10 cigarettes/day.
- Contraindication for periodontal surgery.
- Patients with poor oral hygiene.
- Recession defects associated with caries or restoration as well as
- Teeth with evidence of a pulpal pathology
- Molar teeth
About this study
Official title: Management of Miller Class I & II Gingival Recession Using Conventional Versus Abrasive De-epithelization of Palatal Graft
Management of Miller class I \& II gingival recession using coronally advanced flap combined with conventional de-epithelialized free gingival graft versus coronally advanced flap combined with abrasive de-epithelized connective tissue graft Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference between coronally advanced flap with conventional de-epithelialized free gingival graft and coronally advanced flap with abrasive de-epithelized connective tissue graft in recession depth reduction.
- Conditions
- Gingival Recession
- Being tested
- coronally advanced flap with abrasive de-epithelized graft., coronally advanced flap with de-epithelized graft.
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronally advanced flap with abrasive de-epithelized graft.Procedure or surgery
SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a high-speed hand piece and diamond bur
coronally advanced flap with de-epithelized graft.Procedure or surgery
SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a blade
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | SCTG will be harvested from the palate in the intervention group (coronally advanced flap and abrasively de-epithelialized free gingival graft) Receives: Procedure: coronally advanced flap with abrasive de-epithelized graft. |
| Control group | Active comparator | SCTG will be harvested from the palate using Zucchilli's technique (zucchelli, 2010) in the control group (coronally advanced flap and conventionally de-epithelialized free gingival graft) Receives: Procedure: coronally advanced flap with de-epithelized graft. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct Post-operative pain
Directly will be evaluated post-surgically with Visual Analogue Scale with numbers from 0 to 10 that given to the patients at 7 days follow-up visits.
Measured: 7 days
Indirect Post-operative pain
Indirectly will be evaluated on the basis of the mean consumption of analgesics
Measured: 7 days
Secondary outcomes (7)
Complete Root Coverage
CRC evaluated in patients by single operator clinically using a periodontal probe. Root coverage was deemed complete when the gingival margin is at or above the level of CEJ
Measured: 6 months
Recession depth.
Measured from the CEJ to the most apical extension of the gingival margin
Measured: 6 months
Gingival Recession Width
measured at the level of the CEJ.
Measured: 6 months
Width Of Keratinized Gingiva
Measured from the gingival margin to the mucogingival line
Measured: 6 months
Root Coverage Esthetic Score
The RES system evaluates five variables 6 months following surgery
Measured: 6 months
Gingival thickness
It will be measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove with the periodontal probe after giving local anesthesia to measure the thickness of gingival tissues.
Measured: 6 months
Surgical chair time
measured by Stop watch
Measured: at the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Feb 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halla Gamal Mohammed Esmail
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Halla Gamal Mohammed Esmail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767309
- Sponsor's protocol ID
- 1788
- Status last verified
- Dec 2018
- First submitted
- 29 Nov 2018
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Miller Class I & II Gingival Recession Using Conventional Versus Abrasive De-epithelization of Palatal Graft
- ClinicalTrials.gov ID
- NCT03767309
- Acronym / sponsor ID
- 1788
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Halla Gamal Mohammed EsmailUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 6 Dec 2018 (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.
Management of Miller class I \& II gingival recession using coronally advanced flap combined with conventional de-epithelialized free gingival graft versus coronally advanced flap combined with abrasive de-epithelized connective tissue graft Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference between coronally advanced flap with conventional de-epithelialized free gingival graft and coronally advanced flap with abrasive de-epithelized connective tissue graft in recession depth reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: coronally advanced flap with abrasive de-epithelized graft.SCTG will be harvested from the palate in the intervention group (coronally advanced flap and abrasively de-epithelialized free gingival graft) |
| Control group | Active comparator | Procedure: coronally advanced flap with de-epithelized graft.SCTG will be harvested from the palate using Zucchilli's technique (zucchelli, 2010) in the control group (coronally advanced flap and conventionally de-epithelialized free gingival graft) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Systemically healthy patients.
- Miller's Class I and II recession defects with recession depth ≥ 2mm.
- Presence of identifiable cemento-enamel junction (CEJ).
- Clinical indication and/or patient request for recession coverage.
Key exclusion criteria (7 listed)
- Pregnant females.
- Smoking ˃ 10 cigarettes/day.
- Contraindication for periodontal surgery.
- Patients with poor oral hygiene.
- Recession defects associated with caries or restoration as well as
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 |
|---|---|---|
| coronally advanced flap with abrasive de-epithelized graft.SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a high-speed hand piece and diamond bur | Procedure or surgery | Test group |
| coronally advanced flap with de-epithelized graft.SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a blade | Procedure or surgery | Control group |
Primary outcome
Direct Post-operative pain
Time frame: 7 days
Directly will be evaluated post-surgically with Visual Analogue Scale with numbers from 0 to 10 that given to the patients at 7 days follow-up visits.
Indirect Post-operative pain
Time frame: 7 days
Indirectly will be evaluated on the basis of the mean consumption of analgesics
7 secondary outcomes
Complete Root Coverage
Time frame: 6 months
Recession depth.
Time frame: 6 months
Gingival Recession Width
Time frame: 6 months
Width Of Keratinized Gingiva
Time frame: 6 months
Root Coverage Esthetic Score
Time frame: 6 months
Gingival thickness
Time frame: 6 months
Surgical chair time
Time frame: at the time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing coronally advanced flap with abrasive de-epithelized graft. and coronally advanced flap with de-epithelized graft. in people with Gingival Recession, run by Halla Gamal Mohammed Esmail.
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 7 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: status not confirmed, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Direct Post-operative pain (time frame: 7 days). The study lists 2 primary outcomes in all. 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 17 Jan 2019.