Cleft Lip and PalateNCT03686761
Periodontal Changes Following Mid Maxillary Distraction
A study testing A Involvement with the osteotomy site of the surgery in people with Cleft Lip and Palate and Periodontal Pocket, run by University of Alexandria at 1 site in Egypt.
Trial summary
To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD). Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate, Periodontal Pocket, Attachment Loss, Periodontal
- What is being tested?
- A Involvement with the osteotomy site of the surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2015to Oct 2016
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Severe maxillary hypoplasia and negative anterior overjet
Who cannot join
- Systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periodontal Changes and Gingival Soft Tissue Healing Following Mid Maxillary Distraction in Cleft Lip and Palate Patients
To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).
Read the detailed description
Segmental forward maxillary distraction osteogenesis(DO)was performed. Distractor connecting buccal molar segments to the anterior maxilla was kept for 7 days. Then distraction was performed till overcorrection and consolidated for 3-months. Periodontal clinical parameters were recorded at baseline, 3 and 6-months postoperatively. Gingival crevicular fluid was collected . Soft tissue healing was evaluated clinically and histologically after distraction.
- Being tested
- A Involvement with the osteotomy site of the surgery
- Keywords
- Inflammation, Healing, Distraction, Periodontium
- Medical subject headings
- Cleft Lip, Periodontal Pocket, Periodontal Attachment Loss, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Involvement with the osteotomy site of the surgeryProcedure or surgery
A Involvement with the osteotomy site of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the Receives: Procedure: A Involvement with the osteotomy site of the surgery |
| Control | Active comparator | Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site Receives: Procedure: A Involvement with the osteotomy site of the surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of periodontal inflammatory mediators
periodontal inflammatory mediators IL-1β
Measured: 7 days
Secondary outcomes (4)
Measurement of periodontal inflammatory mediators TNF- α
periodontal inflammatory mediators TNF- α
Measured: 7 days
Assessment of periodontal probing depth
probing depth measurement
Measured: 3 and 6 month
Assessment of clinical attachment loss
clinical attachment loss measurement
Measured: 3 and 6 month
Assessment of periodontal clinical parameters
Gingival index evaluation GI
Measured: 3 and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study startFeb 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Surgical distraction was performed in 20 cleft lip and palate (CLP) subjects with class III malocclusion, gingival GCF were collected from teeth neighboring the osteotomy site and from premolars of the opposite arch as control.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Principal investigator, Marwa Ibrahim Madi, University of Alexandria
- Investigators
- Marwa Madi, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686761
- Sponsor's protocol ID
- 00010556
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Changes and Gingival Soft Tissue Healing Following Mid Maxillary Distraction in Cleft Lip and Palate Patients
- ClinicalTrials.gov ID
- NCT03686761
- Acronym / sponsor ID
- 00010556
- Keywords
- Inflammation, Healing, Distraction, Periodontium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- Feb 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Sep 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.
To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).
Detailed description
Segmental forward maxillary distraction osteogenesis(DO)was performed. Distractor connecting buccal molar segments to the anterior maxilla was kept for 7 days. Then distraction was performed till overcorrection and consolidated for 3-months. Periodontal clinical parameters were recorded at baseline, 3 and 6-months postoperatively. Gingival crevicular fluid was collected . Soft tissue healing was evaluated clinically and histologically after distraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Surgical distraction was performed in 20 cleft lip and palate (CLP) subjects with class III malocclusion, gingival GCF were collected from teeth neighboring the osteotomy site and from premolars of the opposite arch as control.
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Procedure: A Involvement with the osteotomy site of the surgeryA Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the |
| Control | Active comparator | Procedure: A Involvement with the osteotomy site of the surgeryInvolvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Severe maxillary hypoplasia and negative anterior overjet
Key exclusion criteria (1 listed)
- Systemic disease
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 |
|---|---|---|
| A Involvement with the osteotomy site of the surgeryA Involvement with the osteotomy site of the surgery | Procedure or surgery | Control, Study |
Primary outcome
Measurement of periodontal inflammatory mediators
Time frame: 7 days
periodontal inflammatory mediators IL-1β
4 secondary outcomes
Measurement of periodontal inflammatory mediators TNF- α
Time frame: 7 days
Assessment of periodontal probing depth
Time frame: 3 and 6 month
Assessment of clinical attachment loss
Time frame: 3 and 6 month
Assessment of periodontal clinical parameters
Time frame: 3 and 6 month
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 2 Oct 2018.
- 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.
Marwa Madi principal investigator
Alexandria 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 A Involvement with the osteotomy site of the surgery in people with Cleft Lip and Palate and Periodontal Pocket, run by University of Alexandria 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 1 inclusion and 1 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 2 Oct 2018. 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?
Measurement of periodontal inflammatory mediators (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 2 Oct 2018.