NCT05371418

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

January 12, 2022

Last Update Submit

May 7, 2022

Conditions

Keywords

overerupted toothangular bone lossorthodontic intrusion

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

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

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

Device: orthodontic intrusion followed by guided tissue regeneration 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

Also known as: guided tissue regeneration
guided 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)

Also known as: orthodontic intrusion
Orthodontic intrusion followed by GTR

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Rehab Fouad Ghouraba

Tanta, Grabia, 3111, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicBites and Stings

Interventions

Surgical Procedures, OperativeGuided Tissue Regeneration

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Plastic Surgery Procedures

Study Officials

  • Rehab F Ghouraba, PHD

    Tanta University

    PRINCIPAL INVESTIGATOR

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

Locations