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
Primary Purpose
Bone Loss, Occlusion
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
surgical (guided tissue regeneration)
orthodontic intrusion followed by guided tissue regeneration GTR
Sponsored by
About this trial
This is an interventional treatment trial for Bone Loss focused on measuring overerupted tooth, angular bone loss, orthodontic intrusion
Eligibility Criteria
Inclusion Criteria:
- Over erupted tooth with angular bone loss with presence of opposing
- Mobility doesn't exceed grade two
- No gingival recession more than 3mm
Exclusion Criteria:
- Systematic diseases that complicate oral surgery such as hyperparathyroidism, bleeding disorders,....etc.
- Smokers
- Patients with negative attitude towards oral hygiene
Sites / Locations
- Rehab Fouad Ghouraba
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
guided regeneration (GTR) followed by orthodontic intrusion
Orthodontic intrusion followed by GTR
Arm Description
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
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
Outcomes
Primary Outcome Measures
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)
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
Secondary Outcome Measures
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05371418
Brief Title
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
Official Title
Controlled Split Mouth Study of Effect of Orthodontic and Guided Bone Regeneration on Angular Bone Loss of Over-erupted Tooth
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
October 11, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Occlusion
Keywords
overerupted tooth, angular bone loss, orthodontic intrusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
guided regeneration (GTR) followed by orthodontic intrusion
Arm Type
Experimental
Arm Description
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
Arm Title
Orthodontic intrusion followed by GTR
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
surgical (guided tissue regeneration)
Other Intervention Name(s)
guided tissue regeneration
Intervention Description
In group 1 (G1), ten teeth over erupted with angular bone loss were treated by guided tissue regeneration (GTR) followed by Orthodontic intrusion
Intervention Type
Device
Intervention Name(s)
orthodontic intrusion followed by guided tissue regeneration GTR
Other Intervention Name(s)
orthodontic intrusion
Intervention Description
. In group 2 (G2), ten teeth over erupted with angular bone loss were treated by Orthodontic intrusion (OI) followed by guided tissue regeneration (GTR)
Primary Outcome Measure Information:
Title
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated clinically regarding pocket depth and tooth mobility
Description
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)
Time Frame
12-15 months
Title
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
Description
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
Time Frame
12-15 months
Secondary Outcome Measure Information:
Title
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated clinically regarding bleeding upon probing
Description
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)
Time Frame
12-15 months
Title
the effect of GTR followed by OI in G1and OI followed by GTR in G2 evaluated radiographically using CBCT regarding defect depth
Description
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
Time Frame
12-15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over erupted tooth with angular bone loss with presence of opposing
Mobility doesn't exceed grade two
No gingival recession more than 3mm
Exclusion Criteria:
Systematic diseases that complicate oral surgery such as hyperparathyroidism, bleeding disorders,....etc.
Smokers
Patients with negative attitude towards oral hygiene
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab F Ghouraba, PHD
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehab Fouad Ghouraba
City
Tanta
State/Province
Grabia
ZIP/Postal Code
3111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
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
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