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

Immediate Implant Placement in Type ii Socket by Vestibular Socket Therapy Using Collagen Membrane (Randomized Controlled Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Immediate Implant; Vestibular Socket Therapy; Type II Socket
• Intervention / Treatment: Procedure: vestibular socket therapy; Procedure: open flap surgery

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Procedure: open flap surgery; patients will undergo immediate implant placement combined with open flap surgery and labial plate augmentation.
Experimental: Study group	Procedure: vestibular socket therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric change of buccal soft tissue contour	The impressions will be taken using lab scanner to create digital surface models in Standard Triangle Language (STL) format, all STL files will be imported to a digital software. The best-fit algorithm will be used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow-up period.	Baseline and 6 months
change in gingival esthetics	The score incorporates seven domains: mesial papilla, distal papilla, soft tissue level, soft tissue contour, deficient alveolar process, soft tissue color, and texture. Each variable is scored from 0 to 2, with 2 being the best outcome. The total pink esthetic score will be calculated by adding the scores of the seven domains and ranged from 0 to 14 (best overall esthetic outcome).	Baseline and 6 months
chang in Modified Sulcus Bleeding Index	a score of 0-3 will be assigned to each labial and palatal surface of the implant then the average for each implant will be calculated according to the following criteria: Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): June 15, 2025

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0809-12/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No