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Outcome Measures

Primary Outcomes (1)

Change in vestibular depth from baseline to 90 days
The primary outcome was the change in oral vestibular depth at the surgical site, measured in millimeters using a calibrated WHO periodontal probe. Measurements were obtained at baseline (day 0) and during follow-up visits. The endpoint reflects preservation of soft tissue architecture after oroantral communication closure. Greater preservation (smaller reduction from baseline) indicates a more favorable clinical outcome for future prosthetic or implant rehabilitation.
Baseline (day 0) to 90 days postoperatively

Secondary Outcomes (4)

Change in keratinized gingiva width
Baseline (day 0) to 90 days postoperatively
Change in alveolar socket width

Study Arms (2)

Resorbable Collagen Membrane Closure

EXPERIMENTAL

Participants with acute oroantral communication diagnosed within 24 hours after extraction underwent minimally invasive closure using a resorbable heterogeneous collagen membrane (Creos Xenoprotect). After socket debridement and smoothing of sharp bony margins, the membrane was trimmed and inserted in a submucosal position to fully cover the defect. Limited mucoperiosteal elevation was performed without vertical releasing incisions. The membrane was stabilized with horizontal mattress sutures and allowed to integrate and resorb spontaneously. Standardized postoperative care, antibiotics, and follow-up were provided.

Procedure: Resorbable collagen membrane OAC closure

Buccal Advancement Flap (Rehrmann)

ACTIVE COMPARATOR

Participants with acute oroantral communication diagnosed within 24 hours after extraction underwent closure using the conventional Rehrmann buccal advancement flap. Following socket debridement and smoothing of bony margins, a trapezoidal full-thickness mucoperiosteal flap with vertical releasing incisions was elevated, mobilized with periosteal releasing incisions, and advanced coronally to achieve tension-free primary closure. Standardized postoperative care, antibiotics, and follow-up identical to the experimental arm were applied.

Interventions

Resorbable collagen membrane OAC closureProcedure

Minimally invasive closure of acute oroantral communication using a resorbable heterogeneous collagen membrane placed in a submucosal position. After extraction socket debridement and smoothing of sharp bony margins, the membrane was trimmed to overlap the defect and inserted beneath the mucosa to fully cover the communication. Limited mucoperiosteal elevation was performed without vertical releasing incisions. The membrane was stabilized using horizontal mattress sutures to achieve tension-free coverage and was left to integrate and resorb spontaneously. Standardized postoperative antibiotics, sinus precautions, and follow-up visits were applied.

Also known as: Creos Xenoprotect, Collagen membrane closure, Submucosal membrane technique

Resorbable Collagen Membrane Closure

Buccal advancement flap OAC closure

Study Design

Study Type

interventional

Phase

not applicable

Allocation

NON RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

Postoperative clinical measurements were performed by an independent calibrated examiner who was not involved in the surgical procedures. Radiographic density and linear measurements were conducted by trained investigators using standardized protocols. Participants and treating surgeon were not masked due to the nature of the surgical interventions.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: This was a prospective, non-randomized, parallel-group clinical study comparing two surgical techniques for acute oroantral communication closure. Eligible adult patients diagnosed within 24 hours after maxillary posterior tooth extraction were allocated to either submucosal placement of a resorbable collagen membrane or closure using the Rehrmann buccal advancement flap. All procedures were performed by the same experienced oral surgeon using standardized perioperative protocols. Clinical and radiographic outcomes were evaluated over a 90-day follow-up period.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Acute Oroantral Communication Closure: Resorbable Collagen Membrane vs. Buccal Advancement Flap Outcomes

Brief Summary

Registry Overview

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Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Resorbable Collagen Membrane Closure

Buccal Advancement Flap (Rehrmann)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Resorbable Collagen Membrane Closure

Buccal Advancement Flap (Rehrmann)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations