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

Not Applicable

Completed

• Conditions: Soft Tissue Healing
• Interventions: Procedure: socket sealing with dense polytetrafluroethylene membrane; Procedure: Socket sealing by diode laser photocoagulation

• Registration Number: NCT04353999
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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.

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 Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-11
• Study First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dense polytetrafluroethylene membrane	socket sealing with dense polytetrafluroethylene membrane	dPTFE membrane was used to seal the socket after grafting
980 nm diode laser photocoagulation	Socket sealing by 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

Primary Outcome Measures

Name	Time	Method
Soft tissue healing (the changes in the soft tissue color throughout the first month)	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 Outcome Measures

Name	Time	Method
soft tissue thickness in millimeters.	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.
pain score on the visual analogue scale (VAS)	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.
Bone width and height measured in millimeters	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.

Trial Locations

Locations (1)

Faculty of dentistry,Alexandria University; 🇪🇬 Alexandria, Egypt