Gingival Recession Types One(RT1)NCT05976451
Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1
A study testing melatonin with collagen matrix and connective tissue graft (CTG) in people with Gingival Recession Types One(RT1), run by Ain Shams University at 1 site in Egypt.
Trial summary
The primary objective of this study was to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession (MAGR) in recession type one (RT1) Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession Types One(RT1)
- What is being tested?
- melatonin with collagen matrix and connective tissue graft (CTG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 3 Mar 2023
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of RT1 GRs of the maxillary or mandibular arch in the esthetic zone with a GR depth ≥2 mm,
- patients >18 years old,
- Full mouth plaque index score <20%
- Systemically and periodontally healthy patients.
Who cannot join
- Smokers
- Patients with periodontitis stage III and IV were previous surgical treatment of GR,
- Pregnant or breastfeeding women; P
- Patients with para-functional habits or any source of occlusal trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Effect on the Predictability of Different Grafting Materials in Treatment of Gingival Recession RT 1in the Esthetic Zone
The primary objective of this study was to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession (MAGR) in recession type one (RT1)
Read the detailed description
this study was conducted to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession
- Conditions
- Gingival Recession Types One(RT1)
- Being tested
- melatonin with collagen matrix, connective tissue graft (CTG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin with collagen matrixCombination product
(CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT)
connective tissue graft (CTG)Combination product
control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT)
| Study group | Role | What they receive |
|---|---|---|
| collagen matrix | Experimental | melatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT) Receives: Combination Product: melatonin with collagen matrix |
| connective tissue graft (CTG) | Active comparator | connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT) Receives: Combination Product: connective tissue graft (CTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
interproximal clinical attachment level
measured from CEJ to base of pocket depth by using periodontal prob
Measured: 6-9 months
Probing pocket depth (PPD)
from gingival margin to pocket depth measured by mm
Measured: 6-9 months
Recession depth
measure from CEJ to gingival margin by mm
Measured: 6-9 months
Secondary outcomes (1)
Keratinized tissue width
from free gingival groove to MGJ
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Oct 2020
- Primary completion1 Apr 2022
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession Types One(RT1)Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahetab mohamed abdel el wahab, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976451
- Sponsor's protocol ID
- 1011
- Status last verified
- Jul 2023
- First submitted
- 12 Mar 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Effect on the Predictability of Different Grafting Materials in Treatment of Gingival Recession RT 1in the Esthetic Zone
- ClinicalTrials.gov ID
- NCT05976451
- Acronym / sponsor ID
- 1011
- Conditions
- Gingival Recession Types One(RT1)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 4 Aug 2023 (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.
The primary objective of this study was to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession (MAGR) in recession type one (RT1)
Detailed description
this study was conducted to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession
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 |
|---|---|---|
| collagen matrix | Experimental | Combination Product: melatonin with collagen matrixmelatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT) |
| connective tissue graft (CTG) | Active comparator | Combination Product: connective tissue graft (CTG)connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT) |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of RT1 GRs of the maxillary or mandibular arch in the esthetic zone with a GR depth ≥2 mm,
- patients >18 years old,
- Full mouth plaque index score <20%
- Systemically and periodontally healthy patients.
Key exclusion criteria (4 listed)
- Smokers
- Patients with periodontitis stage III and IV were previous surgical treatment of GR,
- Pregnant or breastfeeding women; P
- Patients with para-functional habits or any source of occlusal trauma.
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 |
|---|---|---|
| melatonin with collagen matrix(CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT) | Combination product | collagen matrix |
| connective tissue graft (CTG)control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT) | Combination product | connective tissue graft (CTG) |
Primary outcome
interproximal clinical attachment level
Time frame: 6-9 months
measured from CEJ to base of pocket depth by using periodontal prob
Probing pocket depth (PPD)
Time frame: 6-9 months
from gingival margin to pocket depth measured by mm
Recession depth
Time frame: 6-9 months
measure from CEJ to gingival margin by mm
1 secondary outcome
Keratinized tissue width
Time frame: 6-9 months
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 29 Nov 2023.
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 melatonin with collagen matrix and connective tissue graft (CTG) in people with Gingival Recession Types One(RT1), 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 4 inclusion and 4 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 29 Nov 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?
interproximal clinical attachment level (time frame: 6-9 months). The study lists 3 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 29 Nov 2023; AzTrials last refreshed its copy on 31 Oct 2026.