Bone LossNCT05371418
Comparative Clinical and Radiographical Evaluation of Treatment of Angular Bone Defect Related to Over Erupted Tooth Using GTR Followed by Orthodontic Intrusion Versus Orthodontic Intrusion Followed by GTR
A study testing surgical (guided tissue regeneration) and orthodontic intrusion followed by guided tissue regeneration GTR in people with Bone Loss and Occlusion, run by Tanta University at 1 site in Egypt.
Trial summary
Occlusal prematurity leading to loss of vertical stopping points between teeth can lead to teeth over eruption creating abnormal contact area which favors food accumulation and plaque retention. All these factors can lead to gingival inflammation and bone loss which may be worsen by abnormal occlusal force. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- What is being tested?
- surgical (guided tissue regeneration) and orthodontic intrusion followed by guided tissue regeneration GTR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2020to 30 Oct 2021
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Over erupted tooth with angular bone loss with presence of opposing
- Mobility doesn't exceed grade two
- No gingival recession more than 3mm
Who cannot join
- Systematic diseases that complicate oral surgery such as hyperparathyroidism, bleeding disorders,....etc.
- Smokers
- Patients with negative attitude towards oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Split Mouth Study of Effect of Orthodontic and Guided Bone Regeneration on Angular Bone Loss of Over-erupted Tooth
Occlusal prematurity leading to loss of vertical stopping points between teeth can lead to teeth over eruption creating abnormal contact area which favors food accumulation and plaque retention. All these factors can lead to gingival inflammation and bone loss which may be worsen by abnormal occlusal force. Thus, orthodontic evaluation and treatment with periodontic therapy is mandatory to achieve proper treatment.
Aim of the work: To evaluate and compare clinically and radiographically between effect of guided tissue regeneration (GTR) followed by orthodontic intrusion versus orthodontic intrusion followed by GTR in treatment of over erupted tooth with angular bone loss
Read the detailed description
Abstract Occlusal prematurity leading to loss of vertical stopping points between teeth can lead to teeth over eruption creating abnormal contact area which favors food accumulation and plaque retention. All these factors can lead to gingival inflammation and bone loss which may be worsen by abnormal occlusal force. Thus, orthodontic evaluation and treatment with periodontic therapy is mandatory to achieve proper treatment.
Aim of the work: To evaluate and compare clinically and radiographically between effect of guided tissue regeneration (GTR) followed by orthodontic intrusion versus orthodontic intrusion followed by GTR in treatment of over erupted tooth with angular bone loss Material and methods: Twenty teeth in ten cases were selected with at least two teeth with vertical over eruption and angular bone loss with presence of their opposing for spilt mouth study aged from 20- 35 years old. In group 1 (G1), ten teeth over erupted with angular bone loss were treated by GTR followed by Orthodontic intrusion whereas, in group two (G2) ten teeth over erupted with angular bone loss were treated by orthodontic intrusion followed by GTR. All cases were evaluated clinically for pocket depth (PD), bleeding on probing (BOP), tooth mobility prior starting phase one therapy, at re-evaluation and at six- and 12-months post starting either GTR or orthodontic intrusion. Also, radiographical evaluation was assessed using CBCT scan at end of re-evaluation, at six- and 12-months post starting either GTR or orthodontic intrusion to evaluate amount of orthodontic intrusion, amount of change of bone area and length related to angular defect in both groups.
- Being tested
- surgical (guided tissue regeneration), orthodontic intrusion followed by guided tissue regeneration GTR
- Keywords
- overerupted tooth, angular bone loss, orthodontic intrusion
- Medical subject headings
- Bone Diseases, Metabolic, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical (guided tissue regeneration)Procedure or surgery
Also called guided tissue regeneration
In group 1 (G1), ten teeth over erupted with angular bone loss were treated by guided tissue regeneration (GTR) followed by Orthodontic intrusion
orthodontic intrusion followed by guided tissue regeneration GTRDevice
Also called orthodontic intrusion
. In group 2 (G2), ten teeth over erupted with angular bone loss were treated by Orthodontic intrusion (OI) followed by guided tissue regeneration (GTR)
| Study group | Role | What they receive |
|---|---|---|
| guided regeneration (GTR) followed by orthodontic intrusion | Experimental | Ten over erupted teeth were selected with an angular bone loss with presence of their opposing for spilt mouth study aged from 20- 35 years old, were treated by GTR followed by Orthodontic intrusion Receives: Procedure: surgical (guided tissue regeneration) |
| Orthodontic intrusion followed by GTR | Experimental | Ten over erupted teeth were selected with an angular bone loss with presence of their opposing for spilt mouth study aged from 20- 35 years old, were treated by orthodontic intrusion followed by GTR Receives: Device: orthodontic intrusion followed by guided tissue regeneration GTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated clinically regarding pocket depth and tooth mobility
pocket depth will be measured by mm, and tooth mobility with giving scoreM0: Physiological mobility,M1: Slightly increased mobility,M2: Definitive considerable increase in mobility but no impairment of function, M3: Extreme mobility, loose tooth that would be incompatible in function.
these measurements were done prior starting phase one, one month after finishing phase one (Re-evaluation phase) and at six- and 12-months post starting either GTR or orthodontic intrusion (OI)
Measured: 12-15 months
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated radiographically by cone beam computed tomography (CBCT) regarding bone defect area bymm2 and defect area dimensional changes by mm2
the defect area was measured by mm2 at re-evaluation phase, 6 months post GTR in G1 or OI in G2 and after one year from re-evaluation phase in both groups and defect area dimensional changes by mm2 which was evaluated by subtracting value of bone area at 6 months post GTR in G1 or OI in G2 from bone area at Re-evaluation and and subtracting bone area at one year from re-evaluation from bone area at 6 months post GTR in G1 or OI in G2
Measured: 12-15 months
Secondary outcomes (2)
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated clinically regarding bleeding upon probing
All cases were evaluated clinically for bleeding upon probing (BOP) for score (0) healthy gingiva; no bleeding upon insertion of periodontal probe interproximal, (1) edematous, reddened gingiva; no bleeding upon insertion of periodontal probe interproximal, (2) bleeding without flow upon periodontal probe interproximal, (3)bleeding with flow along gingival margin upon insertion of periodontal probe interproximal (4)copious bleeding upon insertion of periodontal probe interproximal and (5) severe inflammation, marked redness and . These measurements were done prior starting phase one, one month after finishing phase one (Re-evaluation phase) and at six- and 12-months post starting either GTR or orthodontic intrusion (OI)
Measured: 12-15 months
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated radiographically using CBCT regarding defect depth
the defect depth was measured by mm at re-evaluation phase, 6 months post GTR in G1 or OI in G2 and after one year from re-evaluation phase in both groups
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start10 Sep 2020
- Primary completion11 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab ghouraba, Tanta University
- Investigators
- Rehab F Ghouraba, PHD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371418
- Sponsor's protocol ID
- 3333
- Status last verified
- May 2022
- First submitted
- 12 Jan 2022
- Last updated
- 12 May 2022
- 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 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Split Mouth Study of Effect of Orthodontic and Guided Bone Regeneration on Angular Bone Loss of Over-erupted Tooth
- ClinicalTrials.gov ID
- NCT05371418
- Acronym / sponsor ID
- 3333
- Keywords
- overerupted tooth, angular bone loss, orthodontic intrusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 12 May 2022 (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.
Occlusal prematurity leading to loss of vertical stopping points between teeth can lead to teeth over eruption creating abnormal contact area which favors food accumulation and plaque retention. All these factors can lead to gingival inflammation and bone loss which may be worsen by abnormal occlusal force. Thus, orthodontic evaluation and treatment with periodontic therapy is mandatory to achieve proper treatment.
Aim of the work: To evaluate and compare clinically and radiographically between effect of guided tissue regeneration (GTR) followed by orthodontic intrusion versus orthodontic intrusion followed by GTR in treatment of over erupted tooth with angular bone loss
Detailed description
Abstract Occlusal prematurity leading to loss of vertical stopping points between teeth can lead to teeth over eruption creating abnormal contact area which favors food accumulation and plaque retention. All these factors can lead to gingival inflammation and bone loss which may be worsen by abnormal occlusal force. Thus, orthodontic evaluation and treatment with periodontic therapy is mandatory to achieve proper treatment.
Aim of the work: To evaluate and compare clinically and radiographically between effect of guided tissue regeneration (GTR) followed by orthodontic intrusion versus orthodontic intrusion followed by GTR in treatment of over erupted tooth with angular bone loss Material and methods: Twenty teeth in ten cases were selected with at least two teeth with vertical over eruption and angular bone loss with presence of their opposing for spilt mouth study aged from 20- 35 years old. In group 1 (G1), ten teeth over erupted with angular bone loss were treated by GTR followed by Orthodontic intrusion whereas, in group two (G2) ten teeth over erupted with angular bone loss were treated by orthodontic intrusion followed by GTR. All cases were evaluated clinically for pocket depth (PD), bleeding on probing (BOP), tooth mobility prior starting phase one therapy, at re-evaluation and at six- and 12-months post starting either GTR or orthodontic intrusion. Also, radiographical evaluation was assessed using CBCT scan at end of re-evaluation, at six- and 12-months post starting either GTR or orthodontic intrusion to evaluate amount of orthodontic intrusion, amount of change of bone area and length related to angular defect in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| guided regeneration (GTR) followed by orthodontic intrusion | Experimental | Procedure: surgical (guided tissue regeneration)Ten over erupted teeth were selected with an angular bone loss with presence of their opposing for spilt mouth study aged from 20- 35 years old, were treated by GTR followed by Orthodontic intrusion |
| Orthodontic intrusion followed by GTR | Experimental | Device: orthodontic intrusion followed by guided tissue regeneration GTRTen over erupted teeth were selected with an angular bone loss with presence of their opposing for spilt mouth study aged from 20- 35 years old, were treated by orthodontic intrusion followed by GTR |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Over erupted tooth with angular bone loss with presence of opposing
- Mobility doesn't exceed grade two
- No gingival recession more than 3mm
Key exclusion criteria (3 listed)
- Systematic diseases that complicate oral surgery such as hyperparathyroidism, bleeding disorders,....etc.
- Smokers
- Patients with negative attitude towards oral hygiene
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 |
|---|---|---|
| surgical (guided tissue regeneration)Also: guided tissue regenerationIn group 1 (G1), ten teeth over erupted with angular bone loss were treated by guided tissue regeneration (GTR) followed by Orthodontic intrusion | Procedure or surgery | guided regeneration (GTR) followed by orthodontic intrusion |
| orthodontic intrusion followed by guided tissue regeneration GTRAlso: orthodontic intrusion. In group 2 (G2), ten teeth over erupted with angular bone loss were treated by Orthodontic intrusion (OI) followed by guided tissue regeneration (GTR) | Device | Orthodontic intrusion followed by GTR |
Primary outcome
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated clinically regarding pocket depth and tooth mobility
Time frame: 12-15 months
pocket depth will be measured by mm, and tooth mobility with giving scoreM0: Physiological mobility,M1: Slightly increased mobility,M2: Definitive considerable increase in mobility but no impairment of function, M3: Extreme mobility, loose tooth that would be incompatible in function. these measurements were done prior starting phase one, one month after finishing phase one (Re-evaluation phase) and at six- and 12-months post starting either GTR or orthodontic intrusion (OI)
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated radiographically by cone beam computed tomography (CBCT) regarding bone defect area bymm2 and defect area dimensional changes by mm2
Time frame: 12-15 months
the defect area was measured by mm2 at re-evaluation phase, 6 months post GTR in G1 or OI in G2 and after one year from re-evaluation phase in both groups and defect area dimensional changes by mm2 which was evaluated by subtracting value of bone area at 6 months post GTR in G1 or OI in G2 from bone area at Re-evaluation and and subtracting bone area at one year from re-evaluation from bone area at 6 months post GTR in G1 or OI in G2
2 secondary outcomes
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated clinically regarding bleeding upon probing
Time frame: 12-15 months
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated radiographically using CBCT regarding defect depth
Time frame: 12-15 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 12 May 2022.
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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.
Rehab F Ghouraba, PHD principal investigator
Tanta 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 surgical (guided tissue regeneration) and orthodontic intrusion followed by guided tissue regeneration GTR in people with Bone Loss and Occlusion, run by Tanta 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 3 inclusion and 3 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 12 May 2022. 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?
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated clinically regarding pocket depth and tooth mobility (time frame: 12-15 months). 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 12 May 2022.