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
Controlled Split Mouth Study of Effect of Orthodontic and Guided Bone Regeneration on Angular Bone Loss of Over-erupted Tooth
1 other identifier
interventional
10
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedFirst Submitted
Initial submission to the registry
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedMay 12, 2022
May 1, 2022
1.1 years
January 12, 2022
May 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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
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
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
12-15 months
Study Arms (2)
guided regeneration (GTR) followed by orthodontic intrusion
EXPERIMENTALTen 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
EXPERIMENTALTen 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
Interventions
In group 1 (G1), ten teeth over erupted with angular bone loss were treated by guided tissue regeneration (GTR) followed by 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)
Eligibility Criteria
You may qualify if:
- Over erupted tooth with angular bone loss with presence of opposing
- Mobility doesn't exceed grade two
- No gingival recession more than 3mm
You may not qualify if:
- Systematic diseases that complicate oral surgery such as hyperparathyroidism, bleeding disorders,....etc.
- Smokers
- Patients with negative attitude towards oral hygiene
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Rehab Fouad Ghouraba
Tanta, Grabia, 3111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rehab F Ghouraba, PHD
Tanta University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
January 12, 2022
First Posted
May 12, 2022
Study Start
September 10, 2020
Primary Completion
October 11, 2021
Study Completion
October 30, 2021
Last Updated
May 12, 2022
Record last verified: 2022-05