Immediate Implant Placement in Type ii Socket by Vestibular Socket Therapy Using Collagen Membrane

NCT07337837 | Completed

• 1 other identifier: 0809-12/2023
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Immediate implant placement has become a routine and regular clinical practice. When the labial bone plate develops a dehiscence-type defect, delayed implant placement was recommended to give suitable amount of time for soft tissue thickening. However, it has a number of drawbacks, including a lengthy treatment period, the requirement for two surgical procedures, and a potential loss of facial contour. When immediate implant is placed with flap elevation and guided bone regeneration in type II socket, labial bone augmentation results were satisfactory, but in terms of soft tissue, it led to midfacial recession and loss of soft tissue contour, resulting in a compromised final esthetic result. To reduce these drawbacks, implant can be immediately placed by vestibular socket therapy using collagen membrane. Aim of this study: To compare labial bone augmentation in immediate implant placement in type II extraction sockets by using collagen membrane placed by two different modalities.

Conditions

Immediate Implant; Vestibular Socket Therapy; Type II Socket

Outcome Measures

Primary Outcomes (2)

• change in buccal bone thickness

  CBCT will be taken for each patient and Labial bone thickness means the distance between the implant surface and the outer surface of bone

  baseline, 3 months, and 6 months

• change in buccal bone height

  Labial bone height means the distance between the apical end of the implant (which is projected on the baseline image) and the crest of the labial bone of both images

  Baseline, 3 months, and 6 months

Secondary Outcomes (3)

• Volumetric change of buccal soft tissue contour

  Baseline and 6 months

• change in gingival esthetics

  Baseline and 6 months

• chang in Modified Sulcus Bleeding Index

  Baseline and 6 months

Study Arms (2)

Study group

EXPERIMENTAL

Procedure: vestibular socket therapy

Control Group

ACTIVE COMPARATOR

Procedure: open flap surgery

Interventions

open flap surgery PROCEDURE

patients will undergo immediate implant placement combined with open flap surgery and labial plate augmentation.

Control Group

vestibular socket therapy PROCEDURE

patients will undergo immediate implant placement and a mucoperiosteal tunnel will be made through a vestibular incision till labial orifice of the socket, a collagen membrane will be inserted under the tunnel and stabilized by membrane tacks. The space between the membrane and implant will be filled with mixture of allograft and xenograft bone material and any autogenous bone chips harvested from local surgical sites.

Study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes with a single maxillary tooth (second bicuspid to second bicuspid) indicate for extraction due to fracture, badly decayed or endodontic lesionswith expected labial bone defect

You may not qualify if:

• Pregnancy.
• Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
• Periodontal disease or gingival recession.
• Heavy smokers (more than 30 cigarette / day).
• Patients with poor oral hygiene

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: January 13, 2026

Record last verified: 2025-12

Locations

EG (1)