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

Bone Loss Clinical Trial

Official title:

Controlled Split Mouth Study of Effect of Orthodontic and Guided Bone Regeneration on Angular Bone Loss of Over-erupted Tooth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05371418
• Other study ID #: 3333
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: May 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 30, 2021
• Est. primary completion date: October 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Bone Loss
• Occlusion

Intervention

Procedure:
• surgical (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

Device:
• orthodontic intrusion followed by guided tissue regeneration GTR
. In group 2 (G2), ten teeth over erupted with angular bone loss were treated by Orthodontic intrusion (OI) followed by guided tissue regeneration (GTR)

Locations

Country	Name	City	State
Egypt	Rehab Fouad Ghouraba	Tanta	Grabia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)	12-15 months
Secondary	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	12-15 months