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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04566913
Other study ID # 101292
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date May 1, 2021

Study information

Verified date September 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess bucco-lingual dimension of the ridge while using pontic shield technique as a treatment modality for ridge preservation


Description:

• Patients with non-restorable teeth in the esthetic area will be recruited from Faculty of Dentistry in Cairo University A pre-operative cone beam computed tomography ( CBCT ) will be taken to examine the non-restorable tooth , measure bucco-lingual width and exclude any fenestration or dehiscence in the labial bone plate

A non-surgical phase one therapy will be done for the patient as a preparatory phase

Proper oral hygiene measures and chlorohexidene mouthwash will be prescribed after the the first

Reassessment of the case to assure absence of any signs of inflammation and prescence of normal tissues before the surgical procedure

- The area will be anaesthetized using infiltration technique in labial site with 1.5ml of anaesthetic solution and palatal site with 0.3 ml of anaesthetic solution

- Decoronation of the tooth , if the crown is available, will be done to obtain a concave mesio-distal root

- A long shank root resection bur will be used to section the root mesiodistally as far apical as possible , in order to obtain the buccal half attached to the labial bone plate and together the apical and the palatal half will be attached to the palatal bone

- Periotome will be used to distort the periodontal ligaments between the palatal half of the root and palatal alveolar socket wall

- Together the apical and the palatal portions of the root will be delivered , using micro forceps

- Bone curettage will be done in the presence of peraipical infection

- Explorer will be used to exclude mobility of the buccal portion of the root

- The thickness of the buccal portion will be reduced to 2mm

- A large round bur will be used to reduce the height of the buccal portion in a mesiodistal direction.

- A bone grafting material will be placed in the remaining socket


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 10
Est. completion date May 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 50 Years
Eligibility 1-Inclusion Criteria:

1a- non-restorable teeth in the anterior esthetic zone

1b-Teeth not indicated for immediate implant placement for reasons such as acute periapical infection, insufficient buccolingual width, poor economical status

1c- Full mouth plaque score (FMPS )<25% at baseline

1d- Full mouth bleeding score (FMBS )<25% at baseline

1e -Systemically healthy

2-Exclusion Criteria:

2a- Fenestration or dehiscence in buccal plate 2b- Periodontally compromised tooth 2c- Mobility of the tooth or remaining root 2d- Smokers 2e- Pregnancy and lactation

Study Design


Related Conditions & MeSH terms

  • To Assess Bucco-lingual Dimension of the Ridge While Using Pontic Shield Technique as a Treatment Modality for Ridge Preservation

Intervention

Procedure:
Pontic Shield Technique
• Together the apical and the palatal portions of the root in the esthetic region will be delivered and the buccal part is left for assessment of stability of bucco-palatal dimension of alveolar ridge

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bucco-lingual ridge dimension To assess the stability of the ridge after surgical procedure using bone calliper and CBCT via subtractive method technique 6 months
Secondary Labial bone thickness To assess the stability of labial plate after surgical procedure using CBCT via subtractive method technique 6 months
Secondary Gingival thickness assess the the thickness of labial tissue using endodontic spreader to identify a numerical value 3 months