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NCT Number: NCT06835543

Soft Tissue Healing After Tooth Extraction

Statement of the problem: Tooth extraction results in hard and soft tissue loss which complicates prosthodontic rehabilitation, So different techniques of alveolar ridge preservation should be done to maintain hard and soft tissue dimensions.

Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.

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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 Badly Broken Down Vital Teeth

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of oral and dental medicine , Suez university

Suez, Suez Governorate, 123456, Egypt

About this study

Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.

Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region not indicated for immediate implant placement. They will be randomly allocated to two equal groups. Group A (n=95) socket will be grafted with HAM particulate and the socket will be covered with amnion membrane, and group B (n=95) socket will be grafted with HAM particulate and the socket will be covered with chorion membrane. 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

  • Patients who need simple extraction not indicated for immediate implant placement.

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

Amnion membrane.

Procedure

the amnion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material

Chorion membrane

Procedure

chorion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 4-0 resorbable suture material.

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

Secondary outcomes

  1. Healing index

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

    Score (from o to 10, were 0 is no healing and 10 complete healing of tissue )

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Assessment of Amnion Membrane Versus Chorion Membrane for Soft Tissue Healing After Tooth Extraction; a Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Feb 19, 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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