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

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

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Healing
• Intervention / Treatment: Procedure: Socket sealing by diode laser photocoagulation; Procedure: socket sealing with dense polytetrafluroethylene membrane

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry,Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The need for the extraction of nonrestorable maxillary anterior tooth for untreatable caries, endodontic treatment failure or root fracture.
2. Type I postextraction sockets according to the classification proposed by Elian et al. with all bony walls intact .
3. Adult patients (aged 18-50 years).
4. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 980 nm diode laser photocoagulation; 980 nm diode laser was used to coagulate the blood over the bone graft particles and achieve a socket seal after socket grafting	Procedure: Socket sealing by diode laser photocoagulation; 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
Active Comparator: Dense polytetrafluroethylene membrane; dPTFE membrane was used to seal the socket after grafting	Procedure: socket sealing with dense polytetrafluroethylene membrane; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue healing (the changes in the soft tissue color throughout the first month)	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.	at 2nd, 3rd and 4th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
soft tissue thickness in millimeters.	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.	4 months
Bone width and height measured in millimeters	bone dimensions were measured on the baseline cone beam computed tomograph and after 4 months also on the recall cone beam computed tomograph.	4 months
pain score on the visual analogue scale (VAS)	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.	1 week

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman
• Investigators: Principal Investigator: Ahmed A kamal, BDs, Alexandria University

Publications and helpful links

General Publications

• Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available.
• Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
• Landry R, Turnbell R, Howley T. Effectiveness of benzydamyne HCl in the treatment of periodontal post-surgical patients. Res Clin Forums. 1988;10:105-118.
• Johnson K. A study of the dimensional changes occurring in the maxilla following tooth extraction. Aust Dent J. 1969 Aug;14(4):241-4. doi: 10.1111/j.1834-7819.1969.tb06001.x. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: April 11, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ORG 0008839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No