Gingival CleftNCT07210762
Gingival Cleft Development at Two Time Points of Canine Retraction
A study testing Early space closure and Delayed space closure in people with Gingival Cleft and Orthodontic Space Closure, run by Bahria University at 1 site in Pakistan.
Trial summary
The goal of this split-mouth randomized controlled trial is to assess whether the timing of extraction space closure-early vs. delayed initiation-affects the incidence of gingival cleft development in orthodontic patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gingival Cleft, Orthodontic Space Closure
- What is being tested?
- Early space closure and Delayed space closure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2025to 19 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Extraction advised of both first premolars from either maxilla, mandible or both.
- All permanent dentition present apart from third molars.
Who cannot join
- Severe crowding
- Smokers
- Patients with systemic diseases that could interfere with bone remodeling.
- Patients with periodontitis or poor periodontal health.
- Patients who have previously undergone periodontal surgery in the area of interest.
- Patients with other oral health conditions that could complicate the treatment or healing process.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Bahria University of Health Sciences Karachi
Karachi, Sindh
Ali Umar, +923345624708, ali.umar1234@yahoo.com
Ali Umar
About this study
Official title: Gingival Cleft Development at Two Time Points of Canine Retraction: a Split-mouth Randomized Controlled Trial
The goal of this split-mouth randomized controlled trial is to assess whether the timing of extraction space closure-early vs. delayed initiation-affects the incidence of gingival cleft development in orthodontic patients. The main question it aims to answer is:
Does the incidence of gingival cleft development get influenced by the specific time point at which orthodontic space closure is initiated following extraction?
Quadrants will be assigned to the early movement group and the other to the delayed movement group and extractions will be performed accordingly. These will be assessed for the effect on development of gingival cleft development.
- Conditions
- Gingival Cleft, Orthodontic Space Closure
- Being tested
- Early space closure, Delayed space closure
- Keywords
- gingival cleft, Orthodontic Space Closure, gingiva, gingival disease, tooth extraction, tooth socket
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early space closureOther
Space closure will be started 1 week after extraction
Delayed space closureOther
Space closure will be started 8 weeks after extraction
| Study group | Role | What they receive |
|---|---|---|
| Early movement group | Experimental | Canine retraction will be started 1 week after extraction Receives: Other: Early space closure |
| Delayed Movement | Experimental | Canine retraction will be started 8 weeks after extraction Receives: Other: Delayed space closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of gingival clefts after space closure initiation
The primary outcome will be the presence of gingival clefts, which will be measured at 3 months and 6 months after space closure initiation
Measured: start of canine retraction to its completion (approximately 6 months)
Secondary outcomes (4)
craniofacial growth pattern
craniofacial growth pattern from sum of posterior angles
Measured: craniofacial growth pattern will be measured at baseline
gingival biotype
gingival biotype by measuring thickness of gingiva using spreader of size 15
Measured: At baseline (immediately prior to tooth extraction)
buccal bone dehiscence
bone dehiscence will be measured utilizing the periodontal probe(in mm) from the distal marginal ridge of premolar as reference point, on both the buccal and palatal/lingual side.
Measured: Immediately post extraction
canine bulbosity
Maximum height of contour of canine will be measured on the pretreatment cast using the digital vernier caliper
Measured: will be measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start15 Oct 2025 (estimated)
- Primary completion19 Mar 2026 (estimated)
- Study completion19 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival CleftStudies 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
- split-mouth randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Umar, Bahria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210762
- Sponsor's protocol ID
- BUHS-IRB # 174/25
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Cleft Development at Two Time Points of Canine Retraction: a Split-mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07210762
- Acronym / sponsor ID
- BUHS-IRB # 174/25
- Conditions
- Gingival Cleft, Orthodontic Space Closure
- Keywords
- gingival cleft, Orthodontic Space Closure, gingiva, gingival disease, tooth extraction, tooth socket
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 19 Mar 2026 (estimated)
- Study completion
- 19 Jul 2026 (estimated)
- First posted
- 7 Oct 2025 (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 goal of this split-mouth randomized controlled trial is to assess whether the timing of extraction space closure-early vs. delayed initiation-affects the incidence of gingival cleft development in orthodontic patients. The main question it aims to answer is:
Does the incidence of gingival cleft development get influenced by the specific time point at which orthodontic space closure is initiated following extraction?
Quadrants will be assigned to the early movement group and the other to the delayed movement group and extractions will be performed accordingly. These will be assessed for the effect on development of gingival cleft development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Early movement group | Experimental | Other: Early space closureCanine retraction will be started 1 week after extraction |
| Delayed Movement | Experimental | Other: Delayed space closureCanine retraction will be started 8 weeks after extraction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Extraction advised of both first premolars from either maxilla, mandible or both.
- All permanent dentition present apart from third molars.
Key exclusion criteria (6 listed)
- Severe crowding
- Smokers
- Patients with systemic diseases that could interfere with bone remodeling.
- Patients with periodontitis or poor periodontal health.
- Patients who have previously undergone periodontal surgery in the area of interest.
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 |
|---|---|---|
| Early space closureSpace closure will be started 1 week after extraction | Other | Early movement group |
| Delayed space closureSpace closure will be started 8 weeks after extraction | Other | Delayed Movement |
Primary outcome
presence of gingival clefts after space closure initiation
Time frame: start of canine retraction to its completion (approximately 6 months)
The primary outcome will be the presence of gingival clefts, which will be measured at 3 months and 6 months after space closure initiation
4 secondary outcomes
craniofacial growth pattern
Time frame: craniofacial growth pattern will be measured at baseline
gingival biotype
Time frame: At baseline (immediately prior to tooth extraction)
buccal bone dehiscence
Time frame: Immediately post extraction
canine bulbosity
Time frame: will be measured at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early space closure and Delayed space closure in people with Gingival Cleft and Orthodontic Space Closure, run by Bahria University at 1 site in Pakistan.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 Oct 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of gingival clefts after space closure initiation (time frame: start of canine retraction to its completion (approximately 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 7 Oct 2025.