NCT05255341

Brief Summary

After tooth extraction, the residual alveolar ridge generally provides limited bone volume because of ongoing, progressive bone resorption. Healing events within post-extraction sockets reduce the dimensions of the socket over time. Therefore, socket preservation became an indispensable procedure as well as fundamental to prevent bone loss following tooth extraction. Preservation, by the name, is the maintenance of the socket, which is essentially the height and width of the gap that is left after the tooth is removed. It is done by placing a graft material or scaffold immediately into the socket of an extracted tooth to presto preserve bone height, width and density

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

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

July 16, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
Last Updated

March 11, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

February 8, 2022

Last Update Submit

February 24, 2022

Conditions

Keywords

socket preservationvascularized interpositional connective tissue graftalveolar ridge preservation techniquesbovine bone graftroll pedicle graft

Outcome Measures

Primary Outcomes (1)

  • width of alveolar bone

    Two holes will be made in the acrylic stent (3mm and 5 mm below the alveolar crest) on the buccal and palatal extensions within the midline of the tooth to be extracted. The buccopalatal width of the alveolar ridge will be measured at the two assigned points using bone caliper at baseline and 6 months post extraction

    changes in the Width of alveolar bone were measured at 3& 5 mm at baseline,3 months and 6 months

Secondary Outcomes (2)

  • gingival thickness

    changes in the gingival thickness were measured at 3 & 5mm at (baseline,3 months and 6 months)

  • height of the alveolar crest

    changes in height of alveolar crest were measured at baseline, 3 months and 6 months

Study Arms (1)

roll pedicle connective tissue graft with bovine bone

EXPERIMENTAL

1. sulcular incisions were performed on the buccal and lingual aspects of the teeth to be extracted 2. Atraumatic extraction was made by periotome. 3. After tooth extraction the soft tissue was reflected at least 4 mm beyond the alveolar crest margin and the socket was filled with bovine derived xenograft and covered with roll pedicle connective tissue graft as a barrier membrane. 4. This pedicle is rolled under the buccal mucosa.The palatal connective tissue pedicle graft was outlined by full thickness incision along the oblique incision line, and parallel incision given from the mesial line angle of target place and reflected coronally up to the crest of the ridge defect. then a partial thickness incision was made extending beyond the line angles of adjacent incisors and mucogingival junction, leaving the periosteum on the bone. 5. the pedicle graft was rolled from the apical end and secured with interrupted sutures to the labial flap.

Procedure: roll pedicle connective tissue graft with bovine bone

Interventions

rotated pedicle connective tissue graft together with bovine bone applied for socket preservation after tooth extraction

Also known as: vascularized interpositional connective tissue graft
roll pedicle connective tissue graft with bovine bone

Eligibility Criteria

Age27 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with healthy systemic condition.
  • Adult patients ˃ 18 years old.
  • hopeless teeth that need tooth or root extraction in the maxillary esthetic zone.
  • Alveolar socket Grade I and II.
  • Normal platelet counts according to complete blood count (CBC) test done in the screening stage.

You may not qualify if:

  • Acute infection at the extraction site
  • Smokers ˃ 10 cigarettes / day.
  • Medications that may interfere with wound healing
  • History of treatment with bisphosphonates.
  • History of allergic reaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry -Cairo University

Giza, 0020, Egypt

Location

Study Officials

  • noha magdy salem amin

    cairo university- faculty of dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 24, 2022

Study Start

July 16, 2019

Primary Completion

March 1, 2021

Study Completion

September 16, 2021

Last Updated

March 11, 2022

Record last verified: 2022-02

Locations