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Completed

NCT Number: NCT04353999

The Effect of Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation

The main aim of this study was to evaluate clinically the effect of laser photocoagulation in comparison to the non-resorbable dense polytetrafluroethylene (dPTFE) membrane on the soft tissue healing during socket preservation with bovine bone xenograft.

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Key information

Conditions

Soft Tissue Healing

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry,Alexandria University

Alexandria, Egypt

About this study

The study was designed as randomized, controlled, clinical trial. patients who were undergoing tooth extraction and socket preservation were divided into two groups: Group I:980 nm Diode laser was used to seal the socket by photocoagulation .Group II : a non-resorbable dPTFE was used to seal the socket and stabilized by suturing to the soft tissue margins of the socket

All patients were clinically and radiographically evaluated at the baseline and on the second , third and fourth weeks postoperatively.Then recalled after 4 months for the final radiographic examination.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The need for the extraction of nonrestorable maxillary anterior tooth for untreatable caries, endodontic treatment failure or root fracture.
  • Type I postextraction sockets according to the classification proposed by Elian et al. with all bony walls intact .
  • Adult patients (aged 18-50 years).
  • A good standard of oral hygiene, as determined by the registration of an O'Leary Plaque Index of less than or equal to 10% after phase I therapy.

Exclusion criteria

  • The presence of any systemic disease that could complicate bone and soft tissue healing of the grafted socket.
  • The presence of any local factor that may interfere with extraction as tooth ankylosis.
  • Smoking.
  • The presence of bone dehiscence and fenestrations of the post-extractive alveolus (Type II and III sockets).
  • Subjects who had undergone radiation therapy.
  • Patients who had been subjected to or who were under bisphosphonate therapy.

Treatment and study plan

Socket sealing by diode laser photocoagulation

Procedure

tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed using 980 nm diode laser photocoagulation applied in a non-contact mode with a poer output of 1 watt in a continuous wave mode for 3-5 minutes

socket sealing with dense polytetrafluroethylene membrane

Procedure

tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed by a non-resorbable dPTFE membrane that is stabilized by suturing to the soft tissue margins of the socket

Primary outcomes

  1. Soft tissue healing (the changes in the soft tissue color throughout the first month)

    Time frame: at 2nd, 3rd and 4th week

    clinical examination and scoring according to Landry healing index. A score of 1 to 5 was given to the surgical site indicating the improvement of the nature of the soft tissue . A score of 1 meaning the least healing and 5 being excellent healing.

Secondary outcomes

  1. soft tissue thickness in millimeters.

    Time frame: 4 months

    The thickness of the soft tissue in the center of the socket was measured at the baseline and after 4 months on the cone beam computed tomoghraph using the ruler tool to measure the thickness in millimeters.

  2. Bone width and height measured in millimeters

    Time frame: 4 months

    bone dimensions were measured on the baseline cone beam computed tomograph and after 4 months also on the recall cone beam computed tomograph.

  3. pain score on the visual analogue scale (VAS)

    Time frame: 1 week

    Pain was measured on the first , forth and seventh day postoperatively. The visual analogue scale comprises a scale graded from 1 to 100 to express the pain on a a ruler the the patient uses to point out the pain score visually with 0 meaning no pain and 100 meaning maximum pain.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

The Effect of Diode Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation in the Esthetic Zone.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2020
Registry last updated
Apr 21, 2020

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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