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NCT Number: NCT06927453

Soft Tissue Healing During Alveolar Ridge Preservation

Statement of the problem: Alveolar ridge preservation after tooth extractions is considered a challenge in oral surgery daily practice. Dental extraction is a traumatic procedure which leads to loss of alveolar bone. The alveolar bone remodeling, which occurs after tooth extraction, leads to vertical and horizontal bone volume loss. Although placentally derived allografts have been widely applied in medical procedures over the past 100 years, their use in the dental field is relatively new.

The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Badly Broken Maxillary Premolars Indicated for Extraction

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of oral and dental medicine , Suez university

Suez, Suez Governorate, 23568, Egypt

About this study

The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.

materials and methods: Careful extraction of the selected tooth will be performed. Then, the extraction sockets will be randomly allocated into two groups. The HAM particulate will be packed into the extraction socket as a standard method for both groups. Group A (n=24) socket will be covered with Human amnion membrane while group B (n=24) socket will be covered with the prefabricated acrylic splint. Soft tissue healing will be assessed (1ry outcome) every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.Patients who need simple teeth extractions.

Exclusion criteria

  • Patients with inability or anticipated failure to maintain adequate oral hygiene.
  • Pregnant or breast-feeding mothers.
  • Any medical condition or therapy that can affect healing.

Treatment and study plan

Acrylic splint

Procedure

The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site covered with the custom acrylic splint.

No splint

Procedure

The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site will not be covered

Primary outcomes

  1. Soft tissue healing

    Time frame: every day for the first week, day after day second week, once in third and fourth week

    Surface area/intraoral Scanner in mm

Secondary outcomes

  1. post operative pain

    Time frame: every day for the first week, day after day second week, once in third and fourth week

    Visual analog score ( score from 0 to 10 in which 0 is no pain and 10 is maximum pain )

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Assessment of the Effect of Covered Versus Uncovered Human Amniotic Membrane In Soft Tissue Healing During Alveolar Ridge Preservation: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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